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Summary: The Department of Writing at Grand Valley State University invites applications for two Affiliate Faculty of Writing positions to begin Fall 2026. Applicants are expected to have an M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing or a closely related field. Candidates should have expertise and experience in teaching college composition to students from diverse backgrounds. Individuals from all backgrounds, including from underrepresented groups, are encouraged to apply. Successful candidates must be able to effectively engage with students, colleagues, and community members with a broad range of backgrounds and experiences. Required Qualifications and Education: M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing, or a closely related field. Experience and expertise in teaching college composition. Strong communication and interpersonal skills, such as the ability to interact with others with respect and cultural humility. Preferred Qualifications and Education: Graduate coursework in rhetoric and composition or its professional equivalent. Experience in or demonstrated commitment to inclusive pedagogical practices. Experience teaching with a range of technological tools to foster students' digital literacy skills. Responsibilities: The ideal candidate will focus their career on teaching general education first-year writing courses and on continuously developing their professional expertise as a writing instructor. Affiliate Faculty are full-time, teaching faculty with a typical full-time (9-month) teaching load of 12 credit hours per semester, drawn from GVSU's general education writing courses. The position is not tenure track, and there are no scholarship expectations or service obligations. Individuals will be appointed for one academic year on a full-time basis. This may be renewed once for an additional academic year. Thereafter, such individuals may be appointed for three (3) consecutive academic years. Minimum Starting Salary: $51,000; commensurate with experience. Benefits: Affiliate Faculty at GVSU are offered a comprehensive benefits package including medical, vision, dental, life insurance, generous employer retirement contributions, wellness resources and tuition waiver effective on date of hire. Department: The Department of Writing emphasizes teaching excellence using inclusive writing pedagogies. Full-time faculty uphold the values of a liberal arts education while providing a collaborative, experiential learning environment within writing studies. In addition to offering general education courses in first-year writing, creative writing, and professional communication, the department provides a unique 42-credit modular curriculum for students seeking a B.A. or B.S. in writing. College: The College of Liberal Arts and Sciences (CLAS) is the largest college at Grand Valley, offering over 50 bachelor's degrees and a growing number of advanced degrees in the natural and mathematical sciences, the fine arts and humanities, and the social sciences. CLAS is a student-centered learning community that welcomes individuals from various backgrounds and engages in critical inquiry, extending knowledge to enrich and enliven individual and public life. Our faculty are active teacher-scholars committed to offering students an accessible and community-engaged liberal arts and sciences education that prepares them for meaningful careers. There are many opportunities for collaboration within CLAS and across a broad group of partners on and off campus. We are interested in attracting a cohort of new faculty committed to these core values as we seek to foster a community where members from all backgrounds can live, learn, and thrive together. University: Grand Valley State University (GVSU) is a public comprehensive institution located in West Michigan with campuses in Allendale, downtown Grand Rapids, and Holland, plus centers in Detroit, Muskegon and Traverse City. The University attracts more than 22,000 undergraduate and graduate students with high quality programs and state-of-the-art facilities and has been nationally recognized for innovativeness and its contribution to students' social mobility. The greater Grand Rapids metropolitan area has a population of around one million people, is affordable, and offers rich cultural amenities. Grand Valley is located within easy driving distance of Chicago, Detroit, Lake Michigan beaches, and many other superb summer and winter recreational venues. Information can be found at the Community Resources page on Grand Valley State University Human Resources website. How To Apply: Apply online at GVSU Careers. To be considered for the position, applicants must upload the following items to the online application: A cover letter addressing qualifications and your motivation to teach at GVSU Curriculum vitae Teaching philosophy statement Graduate transcripts (unofficial transcripts issued to students are acceptable) The online application will allow you to attach these documents electronically, in the same file location. Applicants selected for interviews will be required to submit official transcripts prior to the interview. If you need technical assistance, email Human Resources (hro@gvsu.edu). Questions about the position may be directed to Department of Writing Chair, Amy Ferdinandt Stolley, at stolleam@gvsu.edu. Application Deadline: Consideration of applicants will begin on Monday, November 10, 2025. The posting may be closed at any time at the discretion of the University thereafter. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Must have the physical stamina to work long hours and/or more than 5 days per week. The requirements listed 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. The information contained in this job description is for compliance with the Americans with Disabilities Act as amended by the ADA Amendment Act (2008), Section 504 of the Rehabilitation Act of 1973, and other applicable federal and state laws that prohibit discrimination on the basis of disability. GVSU will provide reasonable accommodations to qualified individuals with disabilities upon request. See www.gvsu.edu/equalopportunity/. TDD Callers: Call Michigan Relay Center at 711 (in State) or 1-800-833-7833 (out of State). Grand Valley State University is an Antidiscrimination/Equal Opportunity Employer, which includes providing equal opportunity for protected veterans and individuals with disabilities. University policy extends protections to additional identities.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator's brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals. The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed. Responsibilities Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed. If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy. May oversee additional writing and QC work performed by the vendors. For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval. Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively (e.g. comments and questions arising from the writing/review process). Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment. Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents. Develop and drive timelines, and communicate writing process and timelines to team members. Provide status/updates of Regulatory Writing deliverables to management. Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams. May contribute content to safety documents (e.g., DSURs, RMPs). May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices. Comply with established company policies and procedures, and industry and regulatory guidelines. Other duties as assigned. Qualifications BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation. Excellent communication skills both orally and in writing. Ability to work both independently and in cross-functional team environments with minimal supervision. Demonstrated ability to lead development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents. Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. Strong attention to detail with the ability to effectively write/summarize science-and data-driven content into clear, concise, and complete documents. Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively. Ability to work effectively in a fast-paced environment with multiple high-priority projects. Ability to oversee consultants/contractors and serve as a liaison for project purposes. Excellent Project management skills. Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP). #LI-HYBRID Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $173,700.00 - $202,650.00 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer

Why Ryan? Hybrid Work Options Award-Winning Culture Generous Personal Time Off (PTO) Benefits 14-Weeks of 100% Paid Leave for New Parents (Adoption Included) Monthly Gym Membership Reimbursement OR Gym Equipment Reimbursement Benefits Eligibility Effective Day One 401K with Employer Match Tuition Reimbursement After One Year of Service Fertility Assistance Program Four-Week Company-Paid Sabbatical Eligibility After Five Years of Service The Senior Consultant provides advice and guidance to identify tax recovery opportunities through research of tax issues, analysis of data, reconciliations, and completion of complicated calculations. This includes delivering review and audit services for clients, preparing relevant documents, reports and/or client presentations, and gaining an understanding of clients methodology and business activities. A successful Senior Consultant should be able to demonstrate analytical and problem-solving skills, strong tax research skills, and effectively communicate with clients or taxing jurisdictions. This role may also requires certain supervisory tasks such as assigning work, training employees, and checking work for technical accuracy and completeness. They may also assists Managers in developing project workplans and scheduling associated project deliverables and be responsible for maintaining a positive team environment. Education and Experience: Four-year college degree from an accredited institution in practice-relevant area with 3+ years practice-relevant experience. Must have legal research and writing experience. JD with 0 to 3 years of experience in tax research and writing. Experienced paralegal with 5+ years of experience in tax research and writing. Excellent organization and time management skills, strong communication skills, and willingness to learn and be a team player. Computer Skills: To perform this job successfully, an individual must have beginner's knowledge of Microsoft Word, Access, Excel, PowerPoint, Outlook, and Internet navigation and research. Certificates and Licenses: Valid driver's license required. Supervisory Responsibilities: Requires limited supervisory responsibilities, including training peers and checking work for accuracy and completeness. Work Environment: Standard indoor working environment. Occasional long periods of sitting while working at computer. Occasional long periods of standing while copying. Position requires regular interaction with employees and clients both in person and via e-mail and telephone. Equal Opportunity Employer: disability/veteran

We are seeking a Manager, Technical Writing to lead a team of Technical Writers within Manufacturing Operations, including responsibility for documentation supporting both production processes and diagnostic/maintenance workflows. This role will ensure that Zoox's technical content-ranging from manufacturing and maintenance work instructions to fleet diagnostics procedures-is accurate, scalable, and technician-friendly. As the leader of the Technical Writing team, you will manage documentation priorities, mentor writers, and partner closely with engineering, quality, and operations teams. You will play a key role in developing frameworks, tools, and processes that improve the clarity, consistency, and efficiency of Zoox's technical publications, enabling technicians and operators to execute their tasks safely, accurately, and on time. In this role, you will Lead and mentor Technical Writers by providing coaching, feedback, and guidance on best practices to drive performance and growth. Enhance standards, templates, and style guides while building a robust framework for document creation, review, storage, and maintenance across manufacturing, maintenance, and diagnostics. Partner with Engineering, Manufacturing, Tiger teams, Rework Review Board, Base Operations, and other cross functional stakeholders to gather inputs and ensure documentation supports production readiness, training, troubleshooting, and technician effectiveness. Oversee the review and approval process to ensure compliance with ISO, APQP, SAE, and other industry standards, while also supporting both hardware and software tools that affect documentation creation, alignment, or the development of new content, such as functional diagrams and guided diagnostics. Establish and manage dashboards, workflows, and platforms (e.g., Dozuki, Oxygen XML, Confluence, Jira) to streamline creation, tracking, and updates, and also explore external partnership and AI tools to optimize documentation effort. Provide clear weekly and monthly updates, proactively seek stakeholder feedback, and ensure team administration and logistics, enabling on-time delivery of critical documentation. Qualifications Bachelor's degree in Technical Communication, Engineering, or a related field. 10+ years of experience in technical writing, with at least 3-5 years in a leadership or management role. Strong experience in building and maintaining documentation frameworks, including standards, templates, and workflows. Hands-on expertise with documentation tools such as Dozuki, Oxygen, FrameMaker, Confluence, and Jira, with proven ability to streamline documentation processes using dashboards and tracking systems. Demonstrated ability to lead cross-functional collaboration with engineering, manufacturing, and operations teams to ensure documentation supports production readiness and compliance (ISO, APQP, SAE, or similar frameworks). Excellent project management and organizational skills, with a track record of delivering complex documentation programs on time and reporting progress effectively to stakeholders. Bonus Qualifications Hands-on experience with diagnostic or automotive documentation, including familiarity with CAN, UDS, and SAE diagnostic standards. Experience with instructional design, training content creation, or technician enablement programs. Familiarity with CAD visualization tools (3DX, CATIA) or integration of multimedia (photos, video, animations) into technical documentation. $133,000 - $167,000 a year Base Salary Range There are three major components to compensation for this position: salary, Amazon Restricted Stock Units (RSUs), and Zoox Stock Appreciation Rights. A sign-on bonus may be offered as part of the compensation package. The listed range applies only to the base salary. Compensation will vary based on geographic location and level. Leveling, as well as positioning within a level, is determined by a range of factors, including, but not limited to, a candidate's relevant years of experience, domain knowledge, and interview performance. The salary range listed in this posting is representative of the range of levels Zoox is considering for this position. Zoox also offers a comprehensive package of benefits, including paid time off (e.g. sick leave, vacation, bereavement), unpaid time off, Zoox Stock Appreciation Rights, Amazon RSUs, health insurance, long-term care insurance, long-term and short-term disability insurance, and life insurance. About Zoox Zoox is developing the first ground-up, fully autonomous vehicle fleet and the supporting ecosystem required to bring this technology to market. Sitting at the intersection of robotics, machine learning, and design, Zoox aims to provide the next generation of mobility-as-a-service in urban environments. We're looking for top talent that shares our passion and wants to be part of a fast-moving and highly execution-oriented team. Follow us on LinkedIn Accommodations If you need an accommodation to participate in the application or interview process please reach out to accommodations@zoox.com or your assigned recruiter. A Final Note: You do not need to match every listed expectation to apply for this position. Here at Zoox, we know that diverse perspectives foster the innovation we need to be successful, and we are committed to building a team that encompasses a variety of backgrounds, experiences, and skills.

Primary Location: 2200 W. University Drive, McKinney, Texas, 75071 We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities. Job Summary: As directed, provide discipline-specific academic assistance to learners and support the operation and promotion of services. Required Qualifications: Essential Duties and Responsibilities Support learners through individual and/or group tutoring in a variety of modalities. Assist students with course-related equipment and supplies. Create, maintain and assure accuracy of records of students tutored as required under department guidelines. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA). Prepare and present workshops as needed. Assist with daily operations and promotion of services. Be available to work a flexible schedule as needed. Supplemental Functions Perform other duties as assigned. Perform all duties to maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of content within the specified subject field Knowledge of department guidelines and record-keeping Knowledge of related instructional equipment Organization and time management skills Presentation skills Computer and applicable software skills Interpersonal and customer service skills Ability to create a positive and safe tutoring and learning environment Ability to communicate effectively in the English language, both orally and in writing Ability to establish and maintain effective working relationships Ability to assist students in using technology Ability to work independently and collaboratively Physical Demands, Working Conditions and Physical Effort Light Work - Exerting up to 20 pounds of force occasionally, up to 10 pounds of force frequently, and/or a negligible amount of force constantly having to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for the Sedentary Work category and the worker sits most of the time, the job is rated Light Work. Positions in this class typically include talking, hearing, seeing, grasping, standing, walking and repetitive motions, plus stooping, kneeling, crouching, and reaching. Occasional exposure to unpleasant environmental conditions and/or hazards. Occasional outside work. Occasional physical effort required. Required Bachelor's degree with relevant courses and/or skills connected to the tutoring subject. One (1) year of tutoring and/or teaching college-level writing experience. Licenses and Certifications Official transcript(s) required. International transcripts require an English translation and a course-by-course evaluation from an approved agency. Transcripts must be submitted with the application to be considered for this position. This schedule includes shifts on Saturdays. Applicants must be available to work on Saturday. This position is generally limited to working a maximum of 19.5 hours per week. (Maximum hours for employees with more than one part-time position at Collin College may vary.) This position is Security Sensitive, therefore, candidates will be subject to a criminal background check. The above description is an overview of the job. It is not intended to be an all-inclusive list of duties and responsibilities of the job as duties and responsibilities may change with business needs. Collin College reserves the right to add, change, amend, or delete portions of this job description at any time, with or without notice. Reasonable accommodations may be made by Collin College in its discretion to enable individuals with disabilities to perform the essential functions. Required & Preferred Qualifications (if applicable): The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Fair Labor Standards Act (exempt/non-exempt) is designated by position. The employer actively supports Americans with Disabilities Act and will consider reasonable accommodations. This is a Security Sensitive position. Therefore candidates will be subject to a criminal background check.* Compensation Type: Hourly Employment Type: Part time Compensation: $21.50 Hourly For any employment questions, please contact HR at (972) 985-3783 or send an email to: employment@collin.edu. Collin College is an Equal Opportunity Employer and does not discriminate on the basis of any characteristic protected by applicable law.

Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences and partner closely with providers to ensure members are genuinely cared for. We're a team that owns our work with accountability, makes data-driven decisions, embraces continuous learning, and celebrates collaboration - because success is a team sport. It's our mission to be there in the moments that matter most for our members and employees. Join us in creating a community of connected care, where coordinated, quality service is the norm and every member feels valued. The Manager, Proposal Development and Management is responsible for leading the creation of high-quality, persuasive, and professional proposal materials that support Medica's business growth, client retention, and brand credibility. This role oversees a team of communication professionals and plays a key part in shaping proposal strategy, content development, and execution to align with Medica's product and service offerings. Perform other duties as assigned. Key Accountabilities Lead the strategy and execution of RFP communications that enhance Medica's reputation as a trusted health plan Ensure the team responds accurately and timely to RFPs/RFIs/Questionnaires. Collaborate and build strong relationships with internal stakeholders and subject matter experts to write compelling and thorough proposal content Forecast RFP volume and develop resourcing plans to support team capacity. Manage the RFP content library including annual review and consolidation of content and management of technology vendor. Maintain the proposal database to provide weekly dashboard reporting on RFP tracking and status to stakeholders. Lead and develop a team of 12-18 The successful candidate will demonstrate strong leadership in managing a high-performing RFP response team, while exhibiting exceptional writing and editing skills with a focus on clarity, accuracy, and brand alignment. They will proactively develop and maintain proposal content and tools, effectively manage multiple projects and shifting priorities in a fast-paced environment and communicate confidently with executives and cross-functional teams. Required Qualifications Bachelor's degree in business, Communications, English, Marketing, Journalism or equivalent experience in related field 4 years of related experience beyond degree in the health insurance, HMO, or health care industry Writing portfolio for review Strongly Preferred Qualifications Experience managing proposal teams and developing strategic communications Familiarity with proposal automation tools such as RFP360 and RFPIO Proven ability to build and maintain relationships with internal stakeholders Experience in developing sales and business presentations for executive audiences Skills and Abilities Strong business leadership combined with proposal writing expertise Excellent written and verbal communication with attention to grammar and detail Advanced proficiency in MS Word, Excel, PowerPoint, and proposal automation tools Strong project management skills and ability to manage multiple priorities Exceptional interpersonal and relationship-building skills Ability to align content with brand standards and corporate identity This position is an Office role, which requires an employee to work onsite, on average, 3 days per week. We are open to candidates located near one of the following office locations: Minnetonka, MN, Madison, WI, Omaha, NE, or St. Louis, MO. The full salary grade for this position is $87,100 - $149,300. While the full salary grade is provided, the typical hiring salary range for this role is expected to be between $87,100 - $130,620. Annual salary range placement will depend on a variety of factors including, but not limited to, education, work experience, applicable certifications and/or licensure, the position's scope and responsibility, internal pay equity and external market salary data. In addition to base compensation, this position may be eligible for incentive plan compensation in addition to base salary. Medica offers a generous total rewards package that includes competitive medical, dental, vision, PTO, Holidays, paid volunteer time off, 401K contributions, caregiver services and many other benefits to support our employees. The compensation and benefits information is provided as of the date of this posting. Medica's compensation and benefits are subject to change at any time, with or without notice, subject to applicable law. Eligibility to work in the US: Medica does not offer work visa sponsorship for this role. All candidates must be legally authorized to work in the United States at the time of application. Employment is contingent on verification of identity and eligibility to work in the United States. We are an Equal Opportunity employer, where all qualified candidates receive consideration for employment indiscriminate of race, religion, ethnicity, national origin, citizenship, gender, gender identity, sexual orientation, age, veteran status, disability, genetic information, or any other protected characteristic.

Job Title: Director/Senior Director of Medical Writing Location: Hybrid - Waltham, MA. Candidates will be required to be in-office 3 days/week. Role Overview: We are seeking a highly motivated Director/Senior Director of medical writing to join our dynamic, growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal to the company as this person will serve as the head of medical writing, responsible for leading and coordinating the writing initiatives on behalf of the company's two co-lead assets and building the function simultaneously. This position reports to the Chief Operating Officer. The ideal candidate will have a strong background in regulatory writing and success functioning in a small company environment as both an individual contributor and a leader. The candidate should have experience across all phases of drug development and should have the ability to work collaboratively across the R&D organization. A track record of driving fast paced delivery and seamless management of multiple stakeholder needs is critical. Our team values in-person collaboration, and we expect this role to work from our Waltham office at least three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact. Key Responsibilities: Serve as the medical writing subject matter expert on strategic project teams, advising on content, format, and style requirements for documents Manage vendors and contractors, providing guidance on prioritization, timelines, and process management. Develop and implement a document strategy for clinical and regulatory documents including the writing, editing and/or reviewing of protocol synopses, protocols, investigator brochures, clinical study reports, IND sections, eCTD/BLA clinical summaries and briefing books. Collaborate with contributors and reviewers to manage expectations, resolve issues, and ensure alignment on document timelines and content. Lead the development and refinement of medical writing processes, SOPs, templates, and quality control measures to ensure efficient preparation of deliverables. Drive and execute writing strategies across clinical development program(s) ensuring effective collaborations with other functional areas. Qualifications: Experience: 10+ years work experience a medical writer in the biotechnology/pharmaceutical industry Education: BS, MS, or doctorate in a scientific or medical field Skills: Proven ability to write and edit complex material for clarity, accuracy, and consistency Experience managing complex clinical-regulatory writing projects across multiple indications Ability to critically analyze and synthesize complex scientific information Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems (e.g. Veeva Vault, Sharepoint) Deep understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, BLAs and MAAs. Proven ability to develop and implement medical writing processes and standards Strong communication skills with the ability to simply summarize complex information verbally and in written format as well as successfully lead cross functional meetings and reviews Attributes: Self-motivated, action-oriented, and highly organized Must feel comfortable working independently with minimal direction in a fast-paced environment with minimal administrative support Adaptable to changing priorities and able to manage multiple projects simultaneously Strategic thinking and leadership skills Operate with integrity, focus, and clarity Preferred Experience: Knowledge of dermatology or rheumatology Experience working in a pre-revenue company with limited resources and fast timelines Advanced degree Compensation: An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for candidates, who will work in Waltham, MA, is $205,000 to $275,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.