Writing Jobs 2026 (Now Hiring) – Smart Auto Apply

We've scanned millions of jobs. Simply select your favorites, and we can fill out the applications for you.

B logo

Executive Director, Medical Writing

BridgeBio Pharma, Inc.San Francisco, CA
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The primary responsibility for this role is to establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix) at BridgeBio. The ideal candidate must have a strong understanding of health authority guidance(s) and requirements for clinical and regulatory documents, including public disclosure requirements in applicable regions. The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (eg, protocols, clinical study reports, investigator brochures). This person will direct, plan, author, and review documents, as well as manage internal and external Medical Writers, for the preparation of high quality documents. Other responsiblites include managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. Additional oversight of any vendor/contractor leveraged to complete projects. The role requires innovative problem-solving, influencing others, and change-management skills. The Cardiorenal Medical Writing department will support multiple clinical development programs across the Cardiorenal Diseases division of BridgeBio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate). The role reports to the VP of Regulatory Affairs. Responsibilities Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents. Lead medical writing (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, , and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines). Take ownership of processes related to documents and guide teams through these processes Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management Where You'll Work This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA & Palo Alto, CA offices. Who You Are Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry Experienced in medical writing activities for multiple regulatory filings at various development stages Experience managing consultants and their projects Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing Excellent interpersonal, active listening, and influencing skills Strong project management skills, ability to work independently, multi-task, and work effectively under pressure Experience with EndNote, StartingPoint templates, and Veeva Vault preferred Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Posted 30+ days ago

University Of Pittsburgh logo

Assistant Professor Of Writing, Beginning Fall 2026 (Tenure-Stream)

University Of PittsburghBradford, PA
Assistant Professor of Writing, beginning Fall 2026 (Tenure-Stream) The University of Pittsburgh at Bradford is currently seeking a Full-Time Assistant Professor of Writing in the Division of Communication and the Arts, beginning Fall 2025. This is a tenure-stream position. Requirements: MFA in Creative Writing or closely related field (or Ph.D. in Creative Writing), with a strong commitment to teaching undergraduates. Scholarship/creative activities, advising, and service activities are required. Experience teaching at the university or collegiate level is required; a record of publications in creative writing is strongly preferred. Responsibilities: Applicants must be able to teach 12 credits per semester, in writing at the undergraduate level. Courses include Fiction 1 and 2, Poetry 1 and 2, Creative Non-Fiction, and the upper-level Technical Writing class required by our Engineering Technology and Radiological Science programs, as well as supervision of our student literary magazine Baily's Beads. This position is an integral element of our Interdisciplinary Arts major, working with other arts faculty to support IA student progress. Preference will be given to applicants with relevant creative and professional experience. Candidates experienced in working with college students from varied backgrounds and who have applied experience in the field of expertise are encouraged to apply. Apply online at: https://www.join.pitt.edu/ . Please submit a letter of application, C.V., statement of teaching philosophy, and contact information for five professional references, including their name, title, email address, phone number, and their relation to the candidate. (Please Note: All documents must be submitted as PDF files & labeled accurately in Talent Center.) Review of complete applications will begin immediately and continue until the position is filled. www.upb.pitt.edu/faculty-search-information '426409

Posted 30+ days ago

Allegion plc logo

Specification Writing Apprenticeship Program - Architectural Services

Allegion plcGolden Valley, MN
Creating Peace of Mind by Pioneering Safety and Security At Allegion, we help keep the people you know and love safe and secure where they live, work and visit. With more than 30 brands, 12,000+ employees globally and products sold in 130 countries, we specialize in security around the doorway and beyond. Additionally, in 2024 we were awarded the Gallup Exceptional Workplace Award, which recognizes the most engaged workplace cultures in the world. Specification Writer Apprenticeship Program - Minneapolis, MN - June 2026 We are looking for Specification Writers to join our Allegion team as part of our Specification Writing Apprenticeship Program! As a Specification Writer in the program, you will complete two rotations in the span of 9 months. This immersive program includes in depth training and development to prepare you for your role of providing access solutions by creating door hardware specifications. In the first six months of the training program, you will relocate to our training facility in Denver, Colorado. Here you will participate in classroom style training with others in your cohort. During this segment, you will learn about the industry, our products, and codes as well as how to read blueprints. In the last three months of the training program, you will transfer to your permanent location in your respective regional sales office. Here you will prepare for your full-time role by writing specifications with the help and supervision of your team so that you are prepared to hit your market ready for success! Qualified candidates must be legally authorized to be employed in the United States. The company does not intend to provide sponsorship for employment visa status (e.g., H-1B, TN, etc.) for this employment position. What You Will Do: Rotational Training Key Elements: Complete immersive SWAP training program curriculum to increase knowledge about Allegion customers, products and processes. Participate and engage in various manufacturing trainings, product training and program events to deepen you understanding of Allegion systems, processes and customers. Immerse yourself in Allegion's culture by attending networking and professional development events to gain valuable relationships throughout the organization. Learn and master Allegion's state of the art tools, systems, and resources. Graduate from 9-month training program with in depth knowledge of role, best practices, policies, guidelines, and procedures to ensure best in class customer experiences. Full Time Role Responsibilities: Create technical hardware sets and specifications for the architectural community, including code compliance for new construction projects as well as aftermarket requests. Provide solutions to architects on product application requirements. Participate in pre and post installation meetings as needed and assist with revisions, access control coordination, and requests for information during all phases of the project. Exhibit a basic understanding of electro-mechanical products and solutions including access control and software. Communicate door hardware coordination requirements and/or conflicts, such as access control, electrical requirements, and specialty doors. Work in conjunction with Project Coordinator to provide a positive customer experience and deliver on project commitments. Maintain excellent industry/competitor product knowledge by reviewing and understanding market data of competitive activity. Adapt to changes in the marketplace. What You Need to Succeed: High School Diploma required; Associate's or Bachelor's degree in Construction, Architecture, or Technical field preferred Strong mechanical and electronics aptitude Excellent attention to detail with a high level of organization and time management skills Proficiency with MS Office tools Ability to learn industry specific software Exemplary verbal and written communication skills Ability to influence with actionable goals Why Work for Us? Allegion is a Great Place to Grow your Career if: You're seeking a rewarding opportunity that allows you to truly help others. With thousands of employees and customers around the world, there's plenty of room to make an impact. As our values state, "this is your business, run with it". You're looking for a company that will invest in your professional development. As we grow, we want you to grow with us. You want a culture that promotes work-life balance. Our employees enjoy generous paid time off, because at Allegion we recognize that you have a full life outside of work! You want to work for an award-winning company that invests in its people. Allegion is proud to be a recipient of the Gallup Exceptional Workplace Award for the second year in a row, recognizing our commitment to employee engagement, strengths-based development, and unlocking human potential. What You'll Get from Us: Health, dental and vision insurance coverage, helping you "be safe, be healthy". A commitment to your future with a 401K plan, offering a 6% company match and no vesting period Tuition Reimbursement Unlimited PTO Employee Discounts through Perks at Work Community involvement and opportunities to give back so you can "serve others, not yourself" Opportunities to leverage your unique strengths through CliftonStrengths testing and coaching Apply Today! Join our team of experts today and help us make tomorrow's world a safer place! Not sure if your experience perfectly aligns with the role? Studies have shown that some people are less likely to apply to jobs unless they meet every single qualification and every single preferred qualification of a job posting. At Allegion, we are dedicated to building a diverse, inclusive, and authentic workplace. So, if you're excited about this role but your past experience doesn't align perfectly with every item in the job description, we encourage you to apply anyway. You may be just the right candidate for this role. We Celebrate Who We Are! Allegion is committed to building and maintaining a diverse and inclusive workplace. Together, we embrace all differences and similarities among colleagues, as well as the differences and similarities within the relationships that we foster with customers, suppliers and the communities where we live and work. Whatever your background, experience, race, color, national origin, religion, age, gender, gender identity, disability status, sexual orientation, protected veteran status, or any other characteristic protected by law, we will make sure that you have every opportunity to impress us in your application and the opportunity to give your best at work, not because we're required to, but because it's the right thing to do. We are also committed to providing accommodations for persons with disabilities. If for any reason you cannot apply through our career site and require an accommodation or assistance, please contact our Talent Acquisition Team. Allegion plc, 2023 | Block D, Iveagh Court, Harcourt Road, Dublin 2, Co. Dublin, Ireland REGISTERED IN IRELAND WITH LIMITED LIABILITY REGISTERED NUMBER 527370 Allegion is an equal opportunity and affirmative action employer Privacy Policy

Posted 30+ days ago

Columbus State Community College logo

Adjunct - English, Developmental Reading And Writing

Columbus State Community CollegeColumbus, OH

$56+ / hour

Job Description: The Adjunct-English, Developmental Reading and Writing position provides quality instruction and maintains a positive learning environment in the classroom, with major emphasis placed on teaching, supporting, and evaluating students. The adjunct role provides instruction and monitors teaching/learning effectiveness in courses assigned by the Department Chair or other leadership members. The incumbent must exhibit strong organizational skills and the ability to multitask while engaging large groups of people with complicated material. Adjuncts teach pre-college reading or writing courses according to the learning outcomes and best practices in student success outlined by the English Department. Instruction & Student Learning Teaches assigned courses as scheduled. Designs curriculum to foster talent in all students, utilizing effective teaching strategies, with an understanding of traditionally underserved students who may not currently possess college-level skills.. Considers individual differences of students in order to design and support a range of appropriate learning activities. Participates in the identification of students with academic or other needs and responds by utilizing an appropriate resource. Uses technology in a manner appropriate to the nature and objectives of courses and programs and communicates clearly to students the expectations concerning the use of such technology. Keeps accurate and appropriate records in accordance with departmental policies. Maintains attendance records, determines and submits grades timely manner, and in accordance with established policies and procedures of the College, and communicates progress feedback as well as other relevant information to students throughout the semester. Distributes and maintains accurate syllabi that incorporate departmental, college, cross-college, and instructor requirements. Conducts classes punctually and in accordance with the prescribed meeting schedule. Employs appropriate assessment techniques to measure students' performance in achieving course goals and objectives. Engages in periodic meetings with the department, Lead Instructor, and Chairperson relative to teaching duties and professional development. Student Engagement & Advisement Creates a positive classroom atmosphere that encourages active and collaborative learning, student effort, academic challenge, student and faculty interaction, and support for learners. Uses technology to assist in communication with students. Encourages a sense of community among students for learning both inside and outside the classroom. Refers students to appropriate student and academic support services available at the College or in the community. Culture of Respect Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community. Minimum Qualifications Master's degree in English, English Education, or a closely related field. Two (2) years of experience teaching reading and/or writing to adults or students in grades 6-12. Additional Information State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s). Compensation Details: Compensation: $55.88 per contact hour Contact Hour: Two hours equals one contact hour Hours: Maximum of 12 contact hours per week Full Time/Part Time: Part time

Posted 30+ days ago

E logo

Medical Writing Operations Specialist II

Exelixis Inc.Alameda, CA

$102,000 - $144,000 / year

SUMMARY/JOB PURPOSE: This role will perform quality review of regulatory documents to ensure content accuracy and consistency. Document scope includes but is not limited to clinical and nonclinical CTD Module 2 summaries, briefing documents, protocols, investigator brochures, clinical study reports (CSRs), and other types of cross-functional documents and reports. ESSENTIAL DUTIES/RESPONSIBILITIES: Ensure compliance with company and industry standards as well as regulatory expectations, supporting the drug development pipeline through high-quality regulatory submissions that contribute to successful product approvals. Ensure that data and information in complex documents are accurate, consistent with source documents, internally consistent, and meet company standards of style and quality. Edit regulatory documents according to company style guide and American Medical Association (AMA) style. Monitor timelines for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Contribute to the development of process improvements, authoring or editing tools, and the development or revision of internal policies, procedures, and job aids. Participate actively in group meetings and in cross-departmental project teams as needed. Other duties as assigned. SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in a related discipline and a minimum of 5 of related experience; or, MS/MA degree in a related discipline and a minimum of 3 years of related experience; or, Equivalent combination of education and experience. BELS certification is a plus. Experience: Experience in Biotech/Pharmaceutical industry required. 3 to 5 years of quality assurance, clinical development, or laboratory experience; or equivalent experience in the pharmaceutical industry. Strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices. Experience reviewing documents for regulatory submissions (e.g., INDs, NDAs, BLAs, sNDAs, TIIVs, CTDs, clinical protocols, CSRs). Knowledge of AMA style and medical terminology. Familiar with VeevaRIM or other document management system and document authoring technologies. Familiarity with therapeutic area of oncology is preferred. Knowledge, Skills and Abilities: Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Manages time to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work. Strong attention to detail and comfortable working in a fast-paced environment. Ability to work with cross-functional teams in a matrixed team environment, collaborate with a wide variety of team members, and relate effectively to people at all levels of the organization. Team player who demonstrates initiative and applies good judgement. Embraces change and has a flexible and innovative mindset. Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $102,000 - $144,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 30+ days ago

T logo

Cybersecurity Compliance Consultant - Technical Writing / Policy Administration

Truist Financial CorporationRaleigh, NC
The position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to create a profile, which will let you see your application status and any communications. If you already have a profile with us, you can log in to check status. Need Help? If you have a disability and need assistance with the application, you can request a reasonable accommodation. Send an email to Accessibility (accommodation requests only; other inquiries won't receive a response). Regular or Temporary: Regular Language Fluency: English (Required) Work Shift: 1st shift (United States of America) Please review the following job description: Works with key stakeholders, including senior leaders and executives, as well as SMEs to clearly define and document cybersecurity requirements, processes, and procedures. Collaborate with key team members and senior management to drive initiatives to completion and rollout and enhance and maintain the Cybersecurity Policy Administration Program. Responsible for assisting document owners with creating, reviewing, and refreshing various levels of documentation; managing reporting and delivery of cybersecurity capabilities to address risks in our environment. This position will onsite, office-centric (5 days a week), based in a Truist core location (Atlanta GA, Charlotte/Raleigh/Wilson/Greensboro NC, Richmond VA).* ESSENTIAL DUTIES AND RESPONSIBILITIES Following is a summary of the essential functions for this job. Other duties may be performed, both major and minor, which are not mentioned below. Specific activities may change from time to time. Responsible for overseeing the development, implementation and management of Cybersecurity Policy Administration program. Act as the team's Technical Writer to help create, refresh, and combine various levels of documentation. Work with key stakeholders, including senior subject matter experts, to clearly define Cybersecurity requirements and processes. Manage documentation ownership, renewal, and reporting. Present complex concepts in a clear and understandable manner to diverse audiences. QUALIFICATIONS Required Qualifications: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree preferably in regulatory affairs, business, organizational or compliance law, or financial services Five years related experience performing legal, compliance, or other duties such as risk management and/or project management Strong knowledge of cyber governance terms, disciplines and frameworks Preferred Qualifications: Previous Policy Administration experience in Technology or Cybersecurity domains Exceptional technical writing and editing skills Familiarity with Technology regulations and frameworks such as NIST, CRI, NYDFS Knowledge of Cybersecurity tools and technologies Leadership and management abilities, with experience guiding and developing program This position will onsite, office-centric (5 days a week), based in a Truist core location (Atlanta GA, Charlotte/Raleigh/Wilson/Greensboro NC, Richmond VA). For this opportunity: Truist will not sponsor an applicant for work visa status or employment authorization, nor will we offer any immigration-related support for this position (including, but not limited to H-1B, F-1 OPT, F-1 STEM OPT, F-1 CPT, J-1, TN-1 or TN-2, E-3, O-1, or future sponsorship for U.S. lawful permanent residence status.) General Description of Available Benefits for Eligible Employees of Truist Financial Corporation: All regular teammates (not temporary or contingent workers) working 20 hours or more per week are eligible for benefits, though eligibility for specific benefits may be determined by the division of Truist offering the position. Truist offers medical, dental, vision, life insurance, disability, accidental death and dismemberment, tax-preferred savings accounts, and a 401k plan to teammates. Teammates also receive no less than 10 days of vacation (prorated based on date of hire and by full-time or part-time status) during their first year of employment, along with 10 sick days (also prorated), and paid holidays. For more details on Truist's generous benefit plans, please visit our Benefits site. Depending on the position and division, this job may also be eligible for Truist's defined benefit pension plan, restricted stock units, and/or a deferred compensation plan. As you advance through the hiring process, you will also learn more about the specific benefits available for any non-temporary position for which you apply, based on full-time or part-time status, position, and division of work. Truist is an Equal Opportunity Employer that does not discriminate on the basis of race, gender, color, religion, citizenship or national origin, age, sexual orientation, gender identity, disability, veteran status, or other classification protected by law. Truist is a Drug Free Workplace. EEO is the Law E-Verify IER Right to Work

Posted 1 week ago

C logo

Technical Writing Intern

Clear BallotNashua, NH
About Clear Ballot Group As the leader in election innovation, Clear Ballot has introduced a new class of tools and a modern approach to voting, enabling unprecedented speed, accuracy, and transparency that officials and the voting public have sought for decades. Clear Ballot entered the election industry with its first product in 2012, disrupting the industry with the nation's first independent, automated audit, and four years later developed a complete voting system which is now the fastest growing voting system in the industry. Clear Ballot's commitment to ease of use and modern technology means that its browser-based software runs on the most modern operating systems in the industry and will always be up to date. About this role This role will work on revising and updating the content for our official technical documentation package that accompanies our software. Qualified candidates will have a solid understanding of how to write effective product documentation and be familiar with industry-standard content authoring and publishing tools. The ideal candidate will be curious and thoughtful about asking questions to further their understanding of our industry, products, and processes. All Clear Ballot employees have the opportunity to get hands-on with our products (both hardware and software) in our Nashua office. What you'll do Learn what it's like to work as a technical writer at a technology company with extensive documentation requirements. Get experience working with an existing documentation set, making updates, getting content reviewed, and generating outputs while following our established workflow. Work on documentation for supporting both web-based applications and physical hardware. Apply our style standards consistently across all official documentation deliverables. Work on special projects, like prototyping new documentation output formats or reorganizing parts of the documentation set, with supervision and guidance from your fellow tech writers. Learn as much as you want about what goes on behind the scenes of running elections. Provide input in terms of style issues and/or "canned text." Requirements of the Candidate Working towards a degree in technical communications or related field. Proficient with a standard content authoring tool such as MadCap Flare, including concepts such as reusing content and producing different outputs. Experience following a style guide. Along with your resume, please provide a writing sample or samples, including a mixture of conceptual content, procedural documentation, and reference information.

Posted 30+ days ago

E logo

Associate Scientific Regulatory Writing Director

Exelixis Inc.Alameda, CA

$148,500 - $209,500 / year

SUMMARY/JOB PURPOSE (Basic purpose of the job): Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross‑functional documents and reports as needed. ESSENTIAL DUTIES/RESPONSIBILITIES: Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience. Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy. Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables. Assigns and supervises partner regulatory editors for all document tasks unrelated to writing. Proposes and manages timelines for the document development process from initiation through approval. Oversees the assembly of appendices for regulatory submission documents as needed. Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams. Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results. Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members. Contributes to SOP and work instruction development and review for the Regulatory Science Communications team. Other duties as needed. SUPERVISORY RESPONSIBILITIES: No direct reports. Supervises work of junior writers and regulatory editors on document tasks. May direct and review the work of contract writers as needed. May mentor less experienced writers. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or, MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or, PhD in related discipline and a minimum of five years of related experience including industry; or Equivalent combination of education and experience. Active AMWA member with certificate or certification preferred; BELS certification a plus. Experience: Experience in Biotech/Pharmaceutical industry preferred. Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry. Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs). Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications. Familiarity with therapeutic area of oncology. Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards. Advanced knowledge of AMA style, medical terminology, and clinical data analysis. Knowledge, Skills and Abilities: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work. Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work. Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues. Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution. Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships. Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems. Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives. Capable of managing the execution of multiple tasks. Ensures appropriate prioritization and execution for area of responsibility. Proactively anticipates, prioritizes and resolves task-related challenges. Designs and implements solutions to address task-related challenges, taking into consideration the broader impact. Work Environment/Physical Demands: Environment: primarily working indoors. Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $148,500 - $209,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 30+ days ago

T logo

Education Specialist Tutor (Reading, Writing & Math)

Tutor Me EducationClaremont, CA
At Tutor Me Education, we are revolutionizing the way students learn, and we're seeking passionate teachers and tutors with special education experience to provide 1:1 in-home tutoring in Claremont , CA ! If you're committed to making a difference in the lives of students with special needs and helping them achieve academic success, we want to hear from you! About the Role: As an Tutor at Tutor Me Education, you’ll provide personalized, one-on-one tutoring to students with special needs in their homes. You will be responsible for helping students with daily activities, offering moral support, and delivering tailored instruction based on their Individualized Education Plan (IEP). Details: Competitive pay based on specialization ($25–$35/hour). 1.5 hours per week Start ASAP Ideal Candidate: Holds an Education Specialist Credential with Extensive Support Needs authorization (required) Experience supporting students with multiple disabilities , including Specific Language Impairment Familiarity with or experience using AAC (Augmentative and Alternative Communication) devices Strong foundation in teaching early literacy, writing, and basic math skills Ability to break down learning into foundational, achievable goals (e.g., letters, colors, shapes) Patient, nurturing, and able to build trust and rapport Skilled in creating a structured, supportive, and engaging learning environment Reliable, punctual, and able to commit to a consistent weekly schedule Strong communication skills and a collaborative mindset Key Responsibilities: Provide targeted instruction in Reading, Writing, and Math Support foundational learning goals, including identifying letters, colors, and shapes Utilize and support the student’s AAC (Augmentative and Alternative Communication) device to facilitate communication Implement developmentally appropriate strategies tailored to the student’s learning needs Maintain a supportive, patient, and structured learning environment. Student Needs: The student has multiple disabilities, including a Specific Language Impairment Requires individualized instruction and consistent support Uses an AAC device for communication Qualifications: Required: Education Specialist Credential with Extensive Support Needs authorization Experience working with students with multiple disabilities and AAC devices preferred Strong skills in differentiated instruction and foundational academic support Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.

Posted 30+ days ago

Chatham University logo

ECS Writing Tutor

Chatham UniversityPittsburgh, Pennsylvania
We value our students! If you see an open position that is right for you, we encourage you to apply! Qualifications: Current graduate student enrolled in the MFA in Creative Writing program or advanced undergraduates Job Description: Chatham students will tutor Environmental Charter School students taking dual-enrollment courses at Chatham. Tutors may be imbedded in a section of ENG105 and/or they may hold individual appointments with individual ECS students taking ENG105 or other courses. Imbedded tutors will be available before and after each ENG105 class session, for a total of 2 hours each day the class meets. Individual tutors will be scheduled on an as-needed basis. Reports to Dr. David Blackmore All current student employees should notify their other manager(s) if you work multiple jobs on campus at the same time. Additionally, students may not work more than 20 hours per week (combined between all campus jobs) during the academic year. Students may not exceed 980 work hours per calendar year. Student jobs do not automatically roll over to the next academic year or summer. Chatham University strives to promote a campus environment that understands and embraces multiculturalism while increasing individuals' intercultural competence. We actively work to build and sustain a diverse and culturally vibrant campus, which promotes employee and student success and retention. Chatham University is an Equal Opportunity Employer with a strong commitment to diversity, inclusion, and equity. Chatham University does not discriminate on the basis of race, creed, color, religion, gender, gender identity, gender expression, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, age, national origin, age, disability, genetic information, veteran status, marital or family status, political affiliation, or any other characteristic protected by applicable law.

Posted 30+ days ago

MapLight Therapeutics logo

Senior Manager, Medical Writing

MapLight TherapeuticsBurlington, Massachusetts

$168,000 - $205,000 / year

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: Reporting to the Head of Medical Writing, the Senior Manager, Medical Writing will be responsible for directly authoring and managing the development of high-quality medical and scientific documents to support the development, regulatory approval, and commercialization for one or more of our products. This role requires close collaboration with cross-functional teams to ensure timely, compliant, and high-standard deliverables that meet global regulatory requirements. The ideal candidate will have extensive experience in medical writing and scientific communications, with a strong understanding of both early- and late-stage drug development processes. Responsibilities: Author and manage regulatory documents for global submissions in accordance with ICH and other international guidelines, internal standards, and project timelines. Lead and coordinate medical writing activities for assigned programs, including internal teams and external vendors, ensuring timely and accurate submissions to regulatory authorities. Provide strategic input on medical writing deliverables, timelines, and processes during cross-functional meetings. Drive process improvements and serve as a subject matter expert on document types, workflows, and technologies. Partner with the Head of Medical Writing to evaluate and implement innovative approaches to document development, review, and quality control. Partner with the Head of Medical Writing to develop and maintain SOPs, templates, and best practices to ensure consistency and efficiency in document preparation. Oversee contract writers as needed, including defining scopes of work and monitoring deliverables and budgets. Apply therapeutic area and product knowledge to ensure scientific accuracy and clarity in all documents. Collaborate with internal stakeholders to establish style standards and quality control measures for high-quality outputs. Qualifications: Advanced degree (PhD, PharmD) in a scientific discipline preferred; Master’s degree with at least 5 years of medical writing experience in pharma/biotech required. In-depth knowledge of regulatory requirements and guidelines (ICH, GCP, FDA, EMA) and familiarity with AMA style. Exceptional writing, editing, and verbal communication skills. Strong project management skills with the ability to prioritize and manage multiple projects. Proficiency with medical writing tools and software. Meticulous attention to detail and commitment to quality. Solid understanding of the drug development process and strong business acumen. Experience managing vendors and contractors is a plus. Strategic thinker with analytical skills and ability to thrive in a fast-paced environment. Collaborative team player with strong interpersonal skills and ability to build effective relationships across functions and with external partners. Location: This is a hybrid role with three days per week in-office in Burlington, Massachusetts. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave. Salary Range $168,000 - $205,000 USD EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Posted 1 week ago

C logo

Writing Tutor

Charles R. Drew UniversityLos Angeles, California

$17 - $20 / hour

Essential Duties and Responsibilities: Meet with students on a one-to-one or small-group basis to give learning assistance. Maintain a weekly schedule of available hours in the Student Education and Services Center and through the online tutoring services scheduling system for student appointments for tutoring in course content areas and/or learning strategies. Support and develop writing skills, strategies, and grammar 101 techniques Familiar with referencing styles (APA and MLA) Excellent understanding of academic writing such as research and thesis papers in one or more disciplines Keep regular and accurate records of tutoring sessions using the required software and/or relevant forms. Visit applicable classes at least once to make contact with faculty members and to obtain any necessary course syllabi or materials. Attend tutor-training sessions as required by the Learning Specialist or the Dean’s Office. Assist with additional duties as needed; for example, organizing materials, performing student data collection and data reporting, or other duties. Provide requested reports and/or updates on tutoring. EDUCATION: Regionally accredited bachelor’s degree or equivalent of combined education; master’s degree is preferred. Must be in good academic standing at a regionally accredited college or university. Must have completed at least 12-18 units in the assigned content areas. EXPERIENCE: Must have a recommendation from a faculty member. Completion of the applicable course or courses related to the subject matter with a grade of “B” or above. Good English-language communication skills. SKILLS: Good interpersonal communication skills and ease in relating to people from varying educational, cultural, and social backgrounds. Reliability and punctuality. Demonstrates and maintains appropriate and professional behavior. Demonstrated data base management skills. Ability to establish priorities, meet deadlines and attain growth-oriented goals. Must possess excellent computer skills and be proficient in MS Windows, Word, Excel, etc. COMPLEXITY: The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasional stooping. Frequent standing. Constant walking, sitting, climbing, reaching high/low levels, finger movement, feeling, speaking clearly, hearing conversationally, and seeing far and near. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasionally required to work in confined space. MENTAL DEMANDS: The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Frequent variety of unrelated tasks. Constant calculating, interrupted work, a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity. Special Requirements: Ability to work effectively with a diverse community. COVID-19 Vaccination : As a health professions institution of higher education, Charles R. Drew University of Medicine and Science seeks to protect the health and safety of the University community. Accordingly, CDU will require COVID-19 vaccinations for all University students, faculty, and staff subject to limited exceptions and exemptions. The University vaccine requirement has been implemented consistent with federal and state law related to medical exemptions for students, faculty, and staff. Requests for disability and religious accommodations from faculty and staff will be evaluated consistent with the law and University policies and procedures. Hourly Rate Range: $17 for undergraduate students; $20 for graduate students Part Time EEO Statement: Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability or covered veteran status. Fair Chance Statement: Charles R. Drew University of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.

Posted 30+ days ago

Mercer University logo

Assistant/Associate Professor of Writing and Interdisciplinary Studies

Mercer UniversityMacon, Georgia
Application Instructions: External Applicants: Please upload your resume on the Apply screen. Your application will automatically populate your resume details, and you may verify and update data on the My Information page. IMPORTANT: Please review the job posting and load ALL documents required in the job posting to the Resume/CV document upload section at the bottom of the My Experience application page. Use the Select Files button to add multiple documents including your Resume/CV, references, cover letter, and any other supporting documents required in the job posting. The " My Experience" page is the only opportunity to add your required supporting document attachments. You will not be able to modify your application after you submit it . Current Mercer University Employees : Apply from your existing Workday account. Do not apply from the external careers website . Log in to Workday and type Jobs Hub in the search bar. Locate the position and click Apply . Job Title: Assistant/Associate Professor of Writing and Interdisciplinary Studies Department: Liberal Studies College/Division: College Of Professional Advancement Primary Job Posting Location: Macon, GA 31207 Additional Job Posting Locations: (Other locations that this position could be based) Atlanta, GA 30341, Lithia Springs, GA 30122, McDonough, GA 30253 Job Details: Mercer University’s College of Professional Advancement invites applications for an interdisciplinary Assistant or Associate Professor of Writing and Interdisciplinary Studies to join the Department of Liberal Studies. This is a full-time tenure-track position beginning August 1, 2026. Responsibilities : With twelve colleges and schools, Mercer University has a Carnegie Research II classification and offers a vibrant academic community committed to student success and academic excellence. This position will be based at one of Mercer’s metro-Atlanta pr Macon campuses and includes a seven-course teaching load spread across four accelerated 8-week sessions in addition to research expectations and service responsibilities. Additional responsibilities include advising students, participating in faculty committees, attending faculty meetings, engaging in scholarly activity, maintaining on-site office hours, and working collaboratively with colleagues. The appointment is for the traditional nine-month academic year. Qualifications : The successful candidate must hold a Ph.D. in a discipline or field of the humanities or social sciences from an accredited institution at the time of appointment and sufficient education or experience to teach college writing. Demonstrated potential for exemplary teaching and the ability to translate that excellence into a fully online, accelerated format is expected. The successful candidate must be able teach general education courses in our Liberal Studies 100-level academic writing sequence, as well as interdisciplinary core courses for the B.A. in Liberal Studies. The successful candidate will be an outstanding teacher with an active scholarly agenda and a desire to contribute the life of the Department, College, and University by serving a post-traditional student population. Area of study is open, with a preference for candidates whose research apply methods of humanistic inquiry to engage contemporary concerns. The successful candidate must demonstrate the potential for teaching excellence and the ability to translate teaching excellence into a fully online, accelerated format for adult learners. Additional Information: The College of Professional Advancement’s Department of Liberal Studies is an interdisciplinary department that serves the College’s post-traditional student population by offering in-person, hybrid, and fully online B.A. degrees in Liberal Studies (a self-designed interdisciplinary major), World Humanities, and Communication. The Department also supports the University’s General Education program. The department prioritizes high-impact teaching practices in service of student research and experiential learning. Ongoing departmental endeavors include the Coastal Georgia Research Initiative, a certificate in Globalization and Engagement, student e-portfolios, and study abroad experiences for working adults. Apply to join a collaborative group of teacher-scholars committed to educational equity through interdisciplinary inquiry. Required Documents: Interested candidates will complete a brief online application and attach required documentation including a letter of interest, curriculum vitae, teaching philosophy, and names and contact information of three references. Finalists for the position will be asked to have two current letters of recommendation sent directly to: Office of the Dean Writing & Interdisciplinary Studies Faculty Search College of Professional Advancement Mercer University 3001 Mercer University Drive Atlanta, GA 30341-4115 Unofficial transcripts may be requested from finalists as part of the recruitment process for this faculty position; finalists will need to redact any personal or private information including, but not limited to, social security number, birthdate, race, or gender, before submitting the unofficial transcripts. The successful candidate must submit official transcripts prior to employment. Deadline : Applications received by January 12, 2026 will receive priority consideration . Review of applications will continue until the position is filled. Background Check Contingency: Selection of the final candidate is contingent upon a successful background check. About Mercer University Founded in 1833, Mercer University is a distinguished private institution recognized for its commitment to academic excellence, leadership development, and community engagement. With campuses across Georgia, Mercer’s twelve schools and colleges offer a wide range of undergraduate, graduate, and professional programs. The university cultivates a close-knit, student-centered environment where innovation, service, and personal growth are deeply valued. Mercer’s employees are at the heart of its mission, dedicated to advancing innovation, supporting student success, and strengthening both our local and global communities through service. At Mercer, we believe in the power of relationships and the importance of in-person collaboration. Accordingly, our employees are expected to serve in-person as it fosters real-time problem solving, mentoring, and the meaningful connections that strengthen both our work and service to our students and the broader university community. Why Work at Mercer University Mercer University offers a variety of benefits for eligible employees including comprehensive health insurance (for self and dependents), generous retirement contributions , tuition waivers , paid vacation and sick leave , technology discounts, s chedules that allow for work-life balance, and so much more! At Mercer University, a Bear is more than a mascot: it's a frame of mind that begins with a strong desire to make the most out of your career. Mercer Bears do not settle for mediocrity or the status quo. If you're seeking an environment where your passion and determination are embraced, then you want to work at Mercer University. For more information, please visit: https://hr.mercer.edu/prospective/ Scheduled Weekly Hours: 40 Job Family: Faculty Social Sciences EEO Statement: EEO/Veteran/Disability

Posted 3 weeks ago

Restoration 1 logo

Independent contractor for estimate writing in Xactimate

Restoration 1Dallas, Texas

$20 - $80 / hour

Established Restoration and reconstruction company in the Dallas/Ft Worth metroplex in search of independent contractor to write estimates in Xactimate. Must be proficient in Xactimate and have knowledge of job scope in water mitigation and reconstruction of residential properties. Set your own schedule. Requirements include site visit, working with insurance adjusters to establish proper scope and writing estimates in Xactimate. I can accompany this person on all initial visits. This is a remote position. Compensation: $20.00 - $80.00 per hour Restoration Support to Help You Get Your Normal Back At Restoration 1, we help people get their property and life back to normal when they're dealing with water, mold, or fire damage. We understand that our customers are going through a taxing and emotionally trying time. This is why our restoration specialists strive to be attentive, offer upfront communication, and valuable services to our customers. Most people struggle to clean up the mess after a disaster such as a flood or fire. We've created a straightforward process to guide our customers through their property restoration. With one phone call, your life can get back to normal. What We Do Our reputation for fast response, exceptional quality, and commitment has contributed to our growth as a company throughout the United States. Our restoration specialists understand that a disaster and the need for property restoration services can come without warning, and that is why we are always at hand to assist you 24/7! Restoration 1 aims to go the extra mile for our customers and make sure their property is back the way they remember it. This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to Restoration 1 Corporate.

Posted 30+ days ago

Trimble logo

Technical Writing Intern

TrimbleDayton, Ohio

$18 - $23 / hour

Your Title: Technical Writing Intern Job Location: Dayton, OH Our Department: IS Duration: Summer 2026 About Trimble’s Internship Program As a Trimble intern, you will not only gain valuable hands-on experience, but you will also be given challenging, meaningful tasks that will give you insight into what it's like working full-time as a valued member of a team. Our internships are designed to prepare you for your career journey, while growing as a professional through lunch and learns, professional development courses, team building activities, and social networking events with other interns, whether you are in person or remote. Over the course of your internship, we want you to feel like you belong, innovate, and grow personally and professionally. Join Trimble’s community to have a global impact where we value you, your experience, and your skills to propel your career forward. Job Summary Are you passionate about the power of words to inform, engage, and inspire? Do you excel at crafting clear, concise, and compelling content across a diverse range of formats to meet audience needs? The Google Workspace Platform Team at Trimble is seeking a full-time Technical Writing Intern to join our team in Dayton, OH. You'll have the opportunity to utilize your skills in the dynamic world of technical communication, where you'll have the chance to fully utilize and further develop your creative skills while contributing to real-world projects. If you're eager to learn, grow, and make a tangible impact within a supportive and forward-thinking environment, we encourage you to apply. Job Responsibilities You will work closely with the team to ensure all internal documentation for Google Workspace products is clear, current, and accessible. Key tasks include: Write, edit, and proofread articles, user guides, and internal announcements for the Google Workspace Training Hub that adhere to company guidelines and standards used by Trimble staff worldwide. Test product features and review existing documentation to confirm accuracy and completeness. Collaborate on content for AI systems, including updating and managing documentation pertaining to AI technology. Participate in and contribute to the team's processes for content review, documentation standards, and content calendar management. Bring a creative mindset to identify new ideas and opportunities for projects, tasks and processes to help improve business function and overall team effectiveness. Recommended Skills & Experience Rising Junior or Senior at an accredited college or university studying English, Communications, Creative Writing, Technical Writing, Marketing or a related field . Strong command of grammar, punctuation, and style, with a talent for writing clear, concise, and compelling content. Must have a general understanding and working knowledge of Google Docs, Sheets, and Slides. Strong ability to manage time, meet deadlines, and balance multiple priorities. Ability to quickly learn new technical concepts and work collaboratively in a team environment. Additional Skills & Experience Prior coursework or experience in technical writing or content development is a plus. Familiarity with AI concepts and an interest in documenting emerging technologies, not required, but a plus. Application Requirement Applicants must submit 3–5 professional or academic writing samples to demonstrate their technical communication abilities. Visa sponsorship is not available for this position. Candidates must already possess authorization to work in the United States of America without the need for employer sponsorship. Compensation: Trimble provides the following compensation range and general description of other compensation and benefits that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full time schedule. Trimble reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation, depending on circumstances not related to an applicant’s sex or other status protected by local, state, or federal law. Hiring Range $18.32–$22.88 Pay Rate Type Hourly Bonus Eligible? No Commission Eligible? No Benefits: Trimble offers comprehensive core benefits that include Medical, Dental, Vision, Life, Disability, Time off plans and retirement plans. Most of our businesses also offer tax savings plans for health, dependent care and commuter expenses as well as Paid Parental Leave and Employee Stock Purchase Plan. If this position is identified above as commission- or bonus-eligible, the terms of the commission plan or discretionary bonus plan for which you are eligible will be provided following the employee start date. How to Apply: Please submit an online application for this position by clicking on the ‘Apply Now’ button located in this posting. Application Deadline: Applications could be accepted until at least 30 days from the posting date. At Trimble, we are committed to fostering a diverse, inclusive, and equitable workplace where everyone can thrive. Guided by our core values—Belong, Innovate, and Grow—we embrace and celebrate differences, knowing they make us stronger and more innovative. We are proud to be an equal opportunity employer, welcoming individuals of all backgrounds and advancing opportunities while embracing race, color, gender identity, sexual orientation, religion, disability, veteran status, or any other protected and diverse characteristic. We are committed to offering our candidates and employees with disabilities or sincerely held religious beliefs the ability to seek reasonable accommodations in accordance with applicable law and/or where it would not constitute undue hardship for Trimble. For more, please see Trimble's Code of Business Conduct and Ethics at https://investor.trimble.com , under “Corporate Governance.” Our mission to transform the way the world works starts with transforming how we work together. By actively listening, asking questions, and taking intentional actions, we cultivate a culture that provides equitable opportunities for everyone to contribute and grow. Trimble’s Privacy Policy If you need assistance or would like to request an accommodation in connection with the application process, please contact AskPX@px.trimble.com.

Posted 1 week ago

HNTB Corporation logo

Marketing/Writing Intern - Summer 2026

HNTB CorporationMilwaukee, Wisconsin
What We're Looking For Do you love writing and being creative? Are you looking for an opportunity to collaborate in a large, dynamic marketing team environment? Do you want to learn the ins and outs of marketing for one of the nation's leading infrastructure engineering firms? If so, we're looking for an intern with energy and enthusiasm to join our marketing team!Our Milwaukee, WI office is seeking a Marketing/Writing Intern for Summer 2026 to support offices across the HNTB Great Lakes Division. The ideal intern will bring a passion for writing and developing creative marketing pieces. They will also enjoy juggling multiple projects, have enthusiasm to learn, be a team player and want to develop skills for working in a professional environment. Relocation and housing are not provided for this position. On-site parking is available at no cost to our intern.Role Expectations:· Assist with writing portions of a proposal and/or qualifications submittals (from overall layout to design, copywriting and editing).· Update staff resumes and project experience write-ups.· Support general PR and brand building (including brochures, press releases, LinkedIn posts, etc.).· Shadow interview rehearsal preparation meetings.· Shadow marketing specialists at meetings.· Collaborate with graphic designers to create strong, visually appealing messages.· Take notes and update databases.· Assist with daily administrative duties.· Work on special projects and perform other duties, as assigned.· Be in-person in our Milwaukee, WI office three days a week (Tues, Wed, Thurs) throughout the summer. What You’ll Do: Performs a variety of tasks which may be specific to a particular functional area of activity such as preparing reports, tracking and evaluating results, coordinating program developments, answering the phone, receiving messages, transmitting information, making copies, editing documents, handling routine inquires and making appointments. Participates in meetings and interfaces with various teams. Assists management in analyzing various data. Works on special projects and provides research as needed. Performs other duties as assigned. What You’ll Need: High School Diploma/GED or equivalent plus enrolled in a related undergraduate or graduate program What We Prefer: Working knowledge of MS Word, Excel, and PowerPoint Ability to work independently Ability to prioritize work and multi-task Additional Information Click here for benefits information: HNTB Total Rewards Click here to learn more about Equal Opportunity Employer/Disability/Veteran Visa sponsorship is not available for this position.#MZ . Locations: Milwaukee, WI (East Wisconsin Avenue) . . . . . . . . . . . . . . . . . . . NOTICE TO THIRD-PARTY AGENCIES: HNTB does not accept unsolicited resumes from recruiters or agencies. Any staffing/employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of HNTB. HNTB will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person or entity. Staffing/employment agencies who have fee agreements with HNTB must submit applicants to the designated HNTB recruiter to be eligible for placement fees.

Posted 1 day ago

Genmab logo

Associate Director, Medical Writing

GenmabPrinceton, Florida

$160,080 - $240,120 / year

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! We are looking for a highly motivated, independent and talented Associate Director of Medical Writing. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Associate Director of Medical Writing, you will be responsible for contributing to the medical writing portfolio within the clinical and regulatory areas. This includes authoring briefing documents, clinical trial medical synopses, protocols, investigator’s brochures, PIPs, CSRs, Health Authority briefing books, Health Authority responses, and other clinical documentation to support the conduct of trials and regulatory submissions/filings. The Associate Director participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. The Associate Director proactively leads departmental activities and various process improvement initiatives, and shares insights from lessons learned. Your key responsibilities will be: Key Accountabilities Independently author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions. Draft and edit more strategic documents, such as Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals). Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams. Lead submission team activities and oversee the preparation of critical documents. Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions. Act as a mentor for new employees and consultants and serve as a role model for junior writers. Lead the development and review of standard processes and templates. Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. Lead the development and review of standard processes and templates. Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. Lead the development and review of standard processes and templates. Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. Skills and experience Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field preferred; advanced degree preferred. At least 8 years relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience preferred. Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting. Experience authoring clinical trial protocols (Phase 1-3) and clinical components in regulatory filings (NDA, BLA, MAA) is required. Additionally, experience preparing investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Ability to interpret and summarize tabular and graphical data presentations. Moreover, you meet the following personal requirements: Strategic thinker with a big-picture orientation. Thorough, systematic, and organized. Proactive, accountable, and goal oriented. Innovative and a good team player. Excellent at sharing knowledge and acting as a mentor. Superior communication skills, capable of conveying scientific or medical information clearly and concisely. Exceptional planning and coordinating abilities. Ability to manage multiple tasks simultaneously. Extensive knowledge of English grammar. Expert in Microsoft 365. Analytical skills with the ability to interpret and present clinical data and other complex information. Advanced leadership skills to guide and mentor team members. Expertise in managing complex projects and submissions. Strong influence and representation skills in high-level cross-functional teams. Strategic vision to drive departmental goals and initiatives. High level of knowledge of regulatory requirements and compliance For US based candidates, the proposed salary band for this position is as follows: $160,080.00---$240,120.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) . Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Posted 1 day ago

Chatham University logo

First Year Writing Adjunct

Chatham UniversityPittsburgh, Pennsylvania
Chatham University welcomes your interest in employment opportunities and encourages you to review open positions. Please note that Chatham does not accept unsolicited applications. Chatham University seeks to fill Adjunct Instructor opportunities in their First Year Writing program. Individuals with professional experience and training in the areas of rhetoric and composition, literary studies, and/or academic research and writing are encouraged to apply. The First Year Writing curriculum aligns with the University’s core values of sustainability, community engagement, and inclusion. All First Year Writing sections share a common syllabus and schedule of assignments. However, instructors may customize the readings, discussions, and assignment prompts of this course around the topic of their choice and utilize a variety of teaching methods to promote student engagement such as experiential learning, group discussion, project work, multimedia, or other techniques. Chatham University strives to promote a campus environment that understands and embraces multiculturalism while increasing individuals' intercultural competence. We actively work to build a nd sustain a diverse and culturally vibrant campus, which promotes employee and student success and retention. Review of applications is ongoing. Position Summary: Adjunct positions will be filled as needed in First Year Writing. We welcome adjunct faculty who bring creativity, enthusiasm and a collaborative approach to their teaching and course development. Primary Responsibilities: Teaching sections of First Year Writing using a predesigned syllabus template. Consulting and collaborating with other faculty to align course content with departmental teaching goals and objectives. Holding office hours and being available to first-year students for additional support and mentorship. Participating in adjunct instructor training sessions. Required Qualifications: Completion of a master’s degree in English/Literature, Creative/Professional Writing, Rhetoric and Composition or relevant field. Preferred Qualifications: Completion of a doctoral degree in English/Literature, Rhetoric and Composition, or relevant field. Candidates with college teaching and mentoring experience. Candidates with professional and/or lived experiences that advance the university’s commitment to diversity, equity, and inclusion. How to Apply: Interested candidates should visit www.chatham.edu/careers and follow the instructions to complete the application process. Cover letter addressing how your experience and training aligns with the qualifications of the position. Please indicate in your cover letter if you are available for in-person or online teaching or both. Curriculum vitae or resume Contact information for three professional references Chatham University is an Equal Opportunity Employer with a strong commitment to diversity, inclusion, and equity. Persons of color, women, veterans, individuals with disabilities, and members of other underrepresented groups are highly encouraged to apply. Chatham University does not discriminate on the basis of race, color, religion, gender, gender identity, gender expression, sexual orientation, age, or national origin. Chatham University strives to promote a campus environment that understands and embraces multiculturalism while increasing individuals' intercultural competence. We actively work to build and sustain a diverse and culturally vibrant campus, which promotes employee and student success and retention. Chatham University is an Equal Opportunity Employer with a strong commitment to diversity, inclusion, and equity. Chatham University does not discriminate on the basis of race, creed, color, religion, gender, gender identity, gender expression, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, age, national origin, age, disability, genetic information, veteran status, marital or family status, political affiliation, or any other characteristic protected by applicable law.

Posted 30+ days ago

T logo

Cybersecurity Compliance Consultant - Technical Writing / Policy Administration

Truist Financial CorporationCharlotte, NC
The position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to create a profile, which will let you see your application status and any communications. If you already have a profile with us, you can log in to check status. Need Help? If you have a disability and need assistance with the application, you can request a reasonable accommodation. Send an email to Accessibility (accommodation requests only; other inquiries won't receive a response). Regular or Temporary: Regular Language Fluency: English (Required) Work Shift: 1st shift (United States of America) Please review the following job description: Works with key stakeholders, including senior leaders and executives, as well as SMEs to clearly define and document cybersecurity requirements, processes, and procedures. Collaborate with key team members and senior management to drive initiatives to completion and rollout and enhance and maintain the Cybersecurity Policy Administration Program. Responsible for assisting document owners with creating, reviewing, and refreshing various levels of documentation; managing reporting and delivery of cybersecurity capabilities to address risks in our environment. This position will onsite, office-centric (5 days a week), based in a Truist core location (Atlanta GA, Charlotte/Raleigh/Wilson/Greensboro NC, Richmond VA).* ESSENTIAL DUTIES AND RESPONSIBILITIES Following is a summary of the essential functions for this job. Other duties may be performed, both major and minor, which are not mentioned below. Specific activities may change from time to time. Responsible for overseeing the development, implementation and management of Cybersecurity Policy Administration program. Act as the team's Technical Writer to help create, refresh, and combine various levels of documentation. Work with key stakeholders, including senior subject matter experts, to clearly define Cybersecurity requirements and processes. Manage documentation ownership, renewal, and reporting. Present complex concepts in a clear and understandable manner to diverse audiences. QUALIFICATIONS Required Qualifications: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree preferably in regulatory affairs, business, organizational or compliance law, or financial services Five years related experience performing legal, compliance, or other duties such as risk management and/or project management Strong knowledge of cyber governance terms, disciplines and frameworks Preferred Qualifications: Previous Policy Administration experience in Technology or Cybersecurity domains Exceptional technical writing and editing skills Familiarity with Technology regulations and frameworks such as NIST, CRI, NYDFS Knowledge of Cybersecurity tools and technologies Leadership and management abilities, with experience guiding and developing program This position will onsite, office-centric (5 days a week), based in a Truist core location (Atlanta GA, Charlotte/Raleigh/Wilson/Greensboro NC, Richmond VA). For this opportunity: Truist will not sponsor an applicant for work visa status or employment authorization, nor will we offer any immigration-related support for this position (including, but not limited to H-1B, F-1 OPT, F-1 STEM OPT, F-1 CPT, J-1, TN-1 or TN-2, E-3, O-1, or future sponsorship for U.S. lawful permanent residence status.) General Description of Available Benefits for Eligible Employees of Truist Financial Corporation: All regular teammates (not temporary or contingent workers) working 20 hours or more per week are eligible for benefits, though eligibility for specific benefits may be determined by the division of Truist offering the position. Truist offers medical, dental, vision, life insurance, disability, accidental death and dismemberment, tax-preferred savings accounts, and a 401k plan to teammates. Teammates also receive no less than 10 days of vacation (prorated based on date of hire and by full-time or part-time status) during their first year of employment, along with 10 sick days (also prorated), and paid holidays. For more details on Truist's generous benefit plans, please visit our Benefits site. Depending on the position and division, this job may also be eligible for Truist's defined benefit pension plan, restricted stock units, and/or a deferred compensation plan. As you advance through the hiring process, you will also learn more about the specific benefits available for any non-temporary position for which you apply, based on full-time or part-time status, position, and division of work. Truist is an Equal Opportunity Employer that does not discriminate on the basis of race, gender, color, religion, citizenship or national origin, age, sexual orientation, gender identity, disability, veteran status, or other classification protected by law. Truist is a Drug Free Workplace. EEO is the Law E-Verify IER Right to Work

Posted 1 week ago

Mission Graduates logo

Writing Partners

Mission GraduatesSan Francisco, CA
Mission Graduates increases the number of K-12 students in San Francisco's Mission District who are prepared for and complete a college education. We work towards fulfilling our mission through a wide range of after-school support services that serve over 1,500 children, youth and families each year. Our vision is to transform the culture of our neighborhood so that college becomes the expectation for Mission families, rather than the exception. We would like to invite you to volunteer as High School Mentors to work with our incoming High School seniors as they prepare for their college applications. Every summer, Mission Graduates pair Writing Partners with high school students to work one-on-one on writing their personal insight questions (PIQ) for college applications and scholarships, meeting weekly throughout the academic year. Writing Partners are able to cultivate meaningful relationships with youth and provide them with much-needed support in such an important chapter of their lives. If you are looking to give back to your community, develop meaningful relationships, and impact the lives of our San Francisco youth, you are encourage you to apply for this volunteer opportunity. Ask: 11-12 month commitment 1 hr per week, at our College Connect Office June 2024 - May 2025: Personal Statement Workshops, June 2024 followed by weekly 1:1 mentorship

Posted 30+ days ago

B logo

Executive Director, Medical Writing

BridgeBio Pharma, Inc.San Francisco, CA

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.1

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

pay-wall

Job Description

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

The primary responsibility for this role is to establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix) at BridgeBio. The ideal candidate must have a strong understanding of health authority guidance(s) and requirements for clinical and regulatory documents, including public disclosure requirements in applicable regions.

The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (eg, protocols, clinical study reports, investigator brochures). This person will direct, plan, author, and review documents, as well as manage internal and external Medical Writers, for the preparation of high quality documents.

Other responsiblites include managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. Additional oversight of any vendor/contractor leveraged to complete projects. The role requires innovative problem-solving, influencing others, and change-management skills.

The Cardiorenal Medical Writing department will support multiple clinical development programs across the Cardiorenal Diseases division of BridgeBio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate).

The role reports to the VP of Regulatory Affairs.

Responsibilities

  • Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance

  • Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents

  • Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents.

  • Lead medical writing (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, , and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion

  • Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements

  • Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines). Take ownership of processes related to documents and guide teams through these processes

  • Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning

  • Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources

  • Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner

  • Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system

  • Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements

  • Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA & Palo Alto, CA offices.

Who You Are

  • Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry
  • Experienced in medical writing activities for multiple regulatory filings at various development stages
  • Experience managing consultants and their projects
  • Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax
  • Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing
  • Excellent interpersonal, active listening, and influencing skills
  • Strong project management skills, ability to work independently, multi-task, and work effectively under pressure
  • Experience with EndNote, StartingPoint templates, and Veeva Vault preferred

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Financial Benefits:

  • Market leading compensation
  • 401K with 100% employer match on first 3% & 50% on the next 2%
  • Employee stock purchase program
  • Pre-tax commuter benefits
  • Referral program with $2,500 award for hired referrals

Health & Wellbeing:

  • Comprehensive health care with 100% premiums covered - no cost to you and dependents
  • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
  • Hybrid work model - employees have the autonomy in where and how they do their work
  • Unlimited flexible paid time off - take the time that you need
  • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
  • Flex spending accounts & company-provided group term life & disability
  • Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

  • People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
  • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
  • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

pay-wall