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Associate Director, Medical Writing-logo
Associate Director, Medical Writing
US QuintilesDurham, North Carolina
The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions This role reports to the Director of Medical Writing Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities: Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed. Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission) The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines Forecasting, budgeting, resource planning and resource allocation. Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan). Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process. Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents. Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents. Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards. Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables. Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks. Responsible for continual improvement of in-house medical writing. Provides expert medical writing support to other CR&D and CSL groups where required In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance. Participant in bid defense, contract development, work alignment and / or operation meetings. Post-graduate qualifications (PhD or MD preferred) Experience A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization. A minimum of 3 years in a supervisory role A comprehensive understanding of the clinical development process, including the documents that are required at each stage. A comprehensive understanding of medical writing processes, standards and issues. Demonstrated track record in cross-functional, multicultural and international clinical trial teams Excellent verbal, written and presentation skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation Prior experience with submissions in Common Technical Document (CTD) format. Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Posted 30+ days ago

Innovation Product Manager - Gene Writing & Editing (GWE)-logo
Innovation Product Manager - Gene Writing & Editing (GWE)
Integrated DNA TechnologiesCoralville, Iowa
Innovation Product Manager – GWE Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of the Gene Writing and Editing Business Unit and will be located on-site in Coralville, IA. This role’s focus will be on the CRISPR and Synthetic Biology markets. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things. In this role, you will have the opportunity to: Develop business cases to initiate investment or change in behavior to achieve long-term revenue and margin growth objectives in your target market. Maintain complete customer insights through qualitative/quantitative market research and robust customer relationships. Develop and communicate product insights, positioning, and value proposition throughout the organization creating alignment around the goals. Serve as a subject matter expert for product lines and target markets/customers with regular analysis of trends, competitors, channels, standards, etc. Collaborate with Commercial Product Management to support lifecycle management decisions including product obsolescence and discontinuation. The essential requirements of the job include: Bachelor's degree or equivalent in business, life sciences, engineering or similar disciplines Minimum 3 years of experience in Product Management or Commercial departments or equivalent function -- or in scientific / R&D in Gene Editing or highly-related technical background, 5 years of experience preferred. May accept less experience with MBA/MSc/PhD degree. Minimum of 2 years of experience within Life Sciences or related scientific industry. Experience in synthetic biology, functional genomics, or gene editing markets preferred. Demonstrated success defining and launching excellent products. It would be a plus if you also possess previous experience in: Knowledge of CRISPR editing systems and/or synthetic biology solutions Ability to work and influence all levels of the organization from Senior Leaders, Functional Leaders to project managers and practitioners in all functional areas and gain followership Excellent communication, interpersonal, organizational, and leadership skills Advanced degrees (MS, MBA) We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

Posted 30+ days ago

Learning Support Specialist II - Writing Center-logo
Learning Support Specialist II - Writing Center
Columbus State Community CollegeColumbus, OH
Compensation Type: Hourly Compensation: $18.00 Job Summary The Learning Support Specialist 2 (LSS2) performs the duties of a professional tutor. The LSS2 will tutor in-person and is expected to work with students, either one-on-one or in small groups to help them attain a deeper and more substantial command of the assigned subject matter. The LSS2 must be able to work with multiple students and with other tutors present, in a shared tutoring space. The LSS2 will communicate with the department regarding individual student progress and needs. This position is responsible for generating reports from tutoring software and sending them to his/her supervisor. The LSS2 must have a strong command of the subject matter and be able to communicate it effectively to students using a variety of methods and teaching tools. Tutoring Supplements students' understanding and command of the course material for which the students are seeking assistance, outside of class. Tutors for introductory courses in discipline area of expertise only. Helps students to develop and apply appropriate learning and study skills. Meets with students at appointed time. Administrative/Clerical Functions Maintains documentation of all tutoring sessions. Generates department reports for tutoring and maintains documentation of department tutoring interactions. Provides course instructor(s) with communication/information that can be used to facilitate student learning of course content. Advanced use and implementation of the College's tutoring software. Continuous Learning & Mentoring Maintains a thorough knowledge of the course material, as well as multiple instructional methodologies, to accommodate various student learning styles. Attends tutor training sessions. Provides support to Academic Support Leads, LSS, LSS1, Peer Tutors & Supplemental Instructional Leaders. Assists with technical support of tutoring software and reports. Culture of Respect Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community. Minimum Qualifications: Bachelor's Degree in English or a related field Two (2) or more years of teaching and/or tutoring of writing experience in a higher education environment Additional License Requirement: State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s). Full Time/Part Time: Part time Union (If Applicable): Scheduled Hours: 20 Additional Information In order to ensure your application is complete, you must complete the following: Please ensure you have all the necessary documents available when starting the application process. For all faculty positions (Instructor, Annually Contracted Faculty, and Adjunct), you will need to upload an unofficial copy of your transcript when completing your aplication. Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application. If you are a current employee of Columbus State Community College, please log in to Workday to use the internal application process. Thank you for your interest in positions at Columbus State Community College. Once you have applied, the most updated information on the status of your application can be found by visiting your Candidate Home. Please view your submitted applications by logging in and reviewing your status.

Posted 30+ days ago

FAC - Adjunct Faculty Pool - Writing Composition-logo
FAC - Adjunct Faculty Pool - Writing Composition
Franklin Pierce UniversityRindge, NH
Part-Time Teaching Opportunity at Franklin Pierce University, Spring 2024 College of Liberal Arts and Social Sciences The Writing Program in the College of Liberal Arts and Social Sciences is seeking applications from candidates interested in teaching courses on a part-time basis for, and for the purposes of developing a deeper pool of qualified instructors to meet our growing needs. The Writing Program serves all incoming students and second-year students at the University and offers several sections each semester. The Composition sequence is a General and Liberal Education (GLE) requirement for all undergraduate students. Courses have a maximum enrollment cap of 18 students per section. The Composition sequence includes - First-Year Composition Tutorial (GLE110.T) is designed to give writing challenged first-year, first-semester students the support they need to be successful in First-Year Composition. Tutors from the Writing Center are imbedded in these sections, and T students are required to take advantage of tutoring resources. This course has a lower course maximum (15). Meets all the curricular requirements of the non-T GLE110. First-Year Composition (GLE110) is the first-year, first semester requirement of all incoming students. Students learn to attend to the context and purpose of their writing while selecting credible, relevant sources to develop their own ideas. This course also works to refine the ability to analyze and comprehend texts. Addresses Learning Outcomes Critical Reading and Written Communication. Second-Year Composition (GLE230) is designed for second-semester, second-year students . Emphasizing skills and techniques developed in GLE110, students will also learn discipline specific conventions and refine proofreading skills. Most sections have a concentration in Business and Professional Writing, Liberal Arts, or Science Writing. Additionally, students will develop basic presentation skills. Addresses Learning Outcomes Written Communication and Oral Communication. There are also Honors sections offered for both GLE110 and GLE230. Experience and Qualifications: Master's degree in English or related field. Academic work in Composition & Rhetoric a plus. Documented teaching experience at the college level. Demonstrated ability to work effectively with diverse groups of students and a team of instructors. Strong communication and interpersonal skills. Flexibility in scheduling a plus. Adjunct faculty postings are for potential part-time, non-benefited, teaching positions. The applicant pool will be reviewed by the Dean of the College or Designee when searching for candidates to fill the position. Applicants should withdraw their application from the pool if they are no longer available. Notice of Nondiscrimination Franklin Pierce University does not discriminate on the basis of sex and prohibits sex discrimination in any education program or activity that it operates, as required by Title IX and its regulations, including in admission and employment. Diversifying the student body, faculty, and administration is congruent with our mission. We value diverse populations and cultures including, but not limited to, ethnicity, gender, gender identity, national origin, neurodiversity, race, and religion. Franklin Pierce University is an EO/AA/Vet/Disability employer.

Posted 30+ days ago

Content Writing Intern-logo
Content Writing Intern
TreatspacePittsburgh, PA
Treatspace is an award-winning SaaS healthcare startup that is disrupting and improving every day, critical healthcare processes that no longer work in a rapidly changing reimbursement landscape. Our platform, PracticeBeat, is designed to help practices solve these patient access and acquisition challenges using marketing tools such as web design, strategic strategies, and search engine optimization (SEO). We are looking for an incredible Content Writing Intern in the Pittsburgh area to work with, learn from, and support our existing team! What you'll be doing: In this position, you will be part of our marketing team for our PracticeBeat product line. You will be an active part of an experienced, multi-disciplinary (and fun!) team working for medical practices throughout the country. The ideal candidate will have blog writing and editing experience. If you're familiar with producing online content and have an eye for detail, we'd like to meet you. Tasks for this position include the following: Creating and publishing SEO-optimized blogs for our PracticeBeat product line Ensuring all-around consistency (style, fonts, images and tone) Learning to use AI tools to augment (not replace) professional writing skills Participating in a customer approval process from start to finish Requirements: Excellent writing and editing skills in English Some background awareness of SEO Experience doing research using multiple sources Familiarity with web publications Ability to juggle multiple, time-sensitive projects and meet deadlines What attributes will make you successful here: Entrepreneurial, persistent, and competitive spirit with an unrelenting desire to learn and succeed Highly adaptable with an ability to thrive in a changing environment Strong organizational skills and attention to detail/timely follow-up Excellent research and discovery skills with ability to identify opportunities Strong ability to creatively and strategically influence a reader to engage and take action Compensation And Perks This is a paid, part-time position When in the office, snacks and beverages are provided for all employees. Keep your creative juices flowing! Our office is conveniently located in Shadyside, and we currently support a hybrid work-from-home/in-office policy Our office is dog-friendly Is this for you? We hope you'll strongly consider learning and working with us. If this isn't a good fit for you now, please share it with other driven students like yourself. To apply, please submit your resume, cover letter, and samples of your work or a link to your portfolio. Our team will review your submission and contact you regarding the next steps!

Posted 30+ days ago

Part-Time Tutor - Math, Science & Writing (Evergreen)-logo
Part-Time Tutor - Math, Science & Writing (Evergreen)
Ivy Tech Community CollegeLafayette, IN
General Purpose and Scope of the position: These positions are part-time, temporary positions filled each semester on an as-needed basis. This position and the posting will stay open continuously in order to build a pool of qualified candidates for future openings as Adjunct Instructors. Applicants will not be notified unless there is an actual need to fill the position or if the candidate does not meet minimum requirements. Major Responsibilities: Mathematics Tutor Responsibilities include tutoring students in basic mathematics and pre-algebra, and assisting with higher mathematics. Bachelor's degree in Mathematics, Education or related field and willingness to participate in tutor training required. Previous tutoring experience preferred. Writing Tutor Responsibilities include tutoring students in basic writing courses and consulting with students on writing assignments for other courses. Bachelor's degree in English, Education or related field and willingness to participate in tutor training required. Previous tutoring experience preferred. ASA Student Tutor Responsibilities include providing tutorial assistance and/or writing consultation for basic courses. Program-level coursework with a grade of B or better in the field being tutored or other relevant experience required. Recommendation from instructor in subject area being tutored preferred. Must participate in tutor training. Conduct all activities with an appreciation and respect for diversity of people, styles, and views. Promote same as an integral part of one's work. See duties/responsibilities. Selected candidate for employment will be subject to pre-employment background checks, including criminal history check, and any offer of employment will be contingent upon that outcome. Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College's Title IX Coordinator or to the US Department of Education Office of Civil Rights.

Posted 30+ days ago

Affiliate Instructor - Writing-logo
Affiliate Instructor - Writing
Loyola University MarylandBaltimore, MD
Position Title Affiliate Instructor - Writing Employee Type Regular Office/Department Writing (JMA) Work Environment Loyola University Maryland Main Campus Job Type Part time Anticipated Start Date 09/01/2024 Benefits at Loyola https://www.loyola.edu/department/hr/benefits/ If Temporary or Visiting, Estimated End Date Position Duties The Department of Writing at Loyola University Maryland occasionally hires qualified candidates to serve as per course affiliate instructors during the academic year. Per course instructors generally teach one or two courses per semester and serve as the instructor of record for an academic class. Responsibilities include but are not limited to course design, syllabus construction, lecture delivery, classroom management, grading, and supervising students. The only required document is a CV. Compensation Range: $4,000-$4,500 per course Master's, Doctoral or equivalent. Successful candidates for any staff, faculty, or administrative position at Loyola University Maryland will be subject to a pre-employment background check. University Description Loyola University Maryland is a Jesuit, Catholic university committed to the educational and spiritual traditions of the Society of Jesus and to the ideals of liberal education and the development of the whole person. Accordingly, Loyola inspires students to learn, lead, and serve in a diverse and changing world. Loyola's beautiful, historic Evergreen campus is located in Baltimore. Loyola enrolls 4,000 undergraduate and 2,000 graduate students across the Sellinger School of Business and Management, the School of Education, and Loyola College of Arts and Sciences. Founded in 1852, Loyola is one of 27 Jesuit colleges and universities in the United States and the first to bear the name of Saint Ignatius Loyola, founder of the Society of Jesus. Diversity Statement Loyola University Maryland strongly values the benefits that diversity brings to the workplace. In accord with its Ignatian values, the University is committed to creating and promoting a community that recognizes the inherent value and dignity of each person. Loyola University Maryland does not discriminate on the basis of race, sex, color, national or ethnic origin, age, religion, disability, marital status, sexual orientation, gender identity, genetic information, military status, or any other legally protected classification. The University recruits, hires, and promotes in accord with this policy and its Core Values.

Posted 1 week ago

Operations Consultant: Communications And Technical Writing-logo
Operations Consultant: Communications And Technical Writing
Voya Financial Inc.Minneapolis, MN
Together we fight for everyone's opportunity for a better financial future. We will do this together - with customers, partners and colleagues. We will fight for others, not against: We will stand up for and champion everyone's access to opportunities. The status quo is not good enough … we believe every individual and every community deserves access to financial opportunities. We are determined to support both individuals and communities in reaching a better financial future. We know that reaching this future depends on our actions today. Like our Purpose Statement, Voya believes in being bold and committed to action. We are committed to a work environment where the differences that we are born with - and those we acquire throughout our lives - are understood, valued and intentionally pursued. We believe that our employees own our culture and have a responsibility to foster an environment where we all feel comfortable bringing our whole selves to work. Purposefully bringing our differences together to positively influence our culture, serve our clients and enrich our communities is essential to our vision. Are you ready to join a company with a strong purpose and a winning culture? Start your Voyage- Apply Now Get to Know the Opportunity: We are seeking a detail-oriented and strategic Operations Consultant to lead and enhance our information repository related to disability and leave management. Expansion in the leave management segment creates this role within the Learning & Development/Change Communications team. This role will focus on organizing, maintaining, and optimizing operational knowledge, tools, and resources to ensure compliance, consistency, and efficiency for the Voya contact Center and Claims organization. The ideal candidate will have experience in disability and leave management, operational excellence, and knowledge management systems. This role will also flex to support the information repository and change communication strategy in our Health and Wealth business lines. The Contributions You'll Make: Assess current information repository tools, structures, and content related to disability and leave management programs. Develop and implement a comprehensive strategy for organizing and maintaining accurate, accessible, and up-to-date documentation and operational resources. Partner with subject matter experts in customer service, claims, compliance, sales and technology teams to gather and verify content. Create and maintain SOPs, process maps, guides, FAQs, and other documentation supporting disability and leave workflows. Ensure all materials are aligned with internal policies, federal/state regulations, and industry best practices. Identify and implement opportunities for automation, workflow improvement, and process standardization. Identify gaps in communication and knowledge-sharing processes and recommend solutions. Monitor repository usage, gather feedback, and continuously improve structure, accessibility, and content quality. Create comprehensive communication strategies for product launches/enhancements, system training and on-going resource support. Manage governance of content accuracy, aging and review standards. Minimum Knowledge & Experience: 3+ years of experience in operations, process management, technical writing or contact center. Strong knowledge of disability and leave programs (e.g., FMLA, STD/LTD). Experience with knowledge management platforms (e.g., SharePoint, Salesforce). Excellent organizational, analytical, and communication skills. Proven ability to manage multiple projects and work cross-functionally. Preferred Knowledge & Experience: Familiarity with compliance standards and regulatory requirements in disability and leave programs. Experience in change management and process improvement methodologies (e.g., Prosci, Continuous Improvement) Strong technical skills and ability to learn new tools quickly. Compensation Pay Disclosure: Voya is committed to pay that's fair and equitable, which means comparable pay for comparable roles and responsibilities. The below annual base salary range reflects the expected hiring range(s) for this position in the location(s) listed. In addition to base salary, Voya offers incentive opportunities (i.e., annual cash incentives, sales incentives, and/or long-term incentives) based on the role to reward the achievement of annual performance objectives. Please note that this salary information is solely for candidates hired to perform work within one of these locations, and refers to the amount Voya Financial is willing to pay at the time of this posting. Actual compensation offered may vary from the posted salary range based upon the candidate's geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Salaries for part-time roles will be prorated based upon the agreed upon number of hours to be regularly worked. $59,970 - $74,960 USD Be Well. Stay Well. Voya provides the resources that can make a difference in your lives. To us, this means thriving physically, financially, socially and emotionally. Voya benefits are designed to help you do just that. That's why we offer an array of plans, programs, tools and resources with one goal in mind: To help you and your family be well and stay well. What We Offer Health, dental, vision and life insurance plans 401(k) Savings plan - with generous company matching contributions (up to 6%) Voya Retirement Plan - employer paid cash balance retirement plan (4%) Tuition reimbursement up to $5,250/year Paid time off - including 20 days paid time off, nine paid company holidays and a flexible Diversity Celebration Day. Paid volunteer time- 40 hours per calendar year Learn more about Voya benefits (download PDF) Critical Skills At Voya, we have identified the following critical skills which are key to success in our culture: Customer Focused: Passionate drive to delight our customers and offer unique solutions that deliver on their expectations. Critical Thinking: Thoughtful process of analyzing data and problem solving data to reach a well-reasoned solution. Team Mentality: Partnering effectively to drive our culture and execute on our common goals. Business Acumen: Appreciation and understanding of the financial services industry in order to make sound business decisions. Learning Agility: Openness to new ways of thinking and acquiring new skills to retain a competitive advantage. Learn more about Critical Skills Equal Employment Opportunity Voya Financial is an equal-opportunity employer. Voya Financial provides equal opportunity to qualified individuals regardless of race, color, sex, national origin, citizenship status, religion, age, disability, veteran status, creed, marital status, sexual orientation, gender identity, genetic information, or any other status protected by state or local law. Reasonable Accommodations Voya is committed to the inclusion of all qualified individuals. As part of this commitment, Voya will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please reference resources for applicants with disabilities. Misuse of Voya's name in fraud schemes

Posted 30+ days ago

Proposal Content (Writing) Manager-logo
Proposal Content (Writing) Manager
Motorola SolutionsChicago, IL
Company Overview At Motorola Solutions, we believe that everything starts with our people. We're a global close-knit community, united by the relentless pursuit to help keep people safer everywhere. Our critical communications, video security and command center technologies support public safety agencies and enterprises alike, enabling the coordination that's critical for safer communities, safer schools, safer hospitals and safer businesses. Connect with a career that matters, and help us build a safer future. Department Overview Motorola Solutions is a global leader in public safety and enterprise security. Our Proposal Center is an integrable part of the organization, helping sales teams deliver winning proposals. The Proposal Center is composed of State and Local solicited RFP teams, a Federal proposal group, plus Writing and Tools Teams. Job Description A Proposal Content (Writing) Manager plays an active role in developing and maintaining high-quality proposal content for use in both competitive and non-competitive proposals. This role works with Sales and Presale teams, Product Managers, and Marketing professionals to ensure the availability of clear, persuasive, compelling proposal content. Responsibilities of the Proposal Content Manager include but are not limited to: Works with Subject Matter Experts (SMEs) to review and update documents that explain how our solution(s) meet customer requirements, goals, and desires and crafts language to support our value proposition. Establishes and maintains relationships with SMEs, aimed at ensuring that all Standard Content Library documents are reviewed at least annually to determine if the documents are still valid and relevant as well as to update the documents so that they remain accurate and complete. Follows up relentlessly to ensure that reviews are completed in a timely fashion and updated documents are posted in the Standard Content Library. Executes, evaluates, and continually improves processes for contacting SMEs and requesting annual reviews. As part of the review process, checks all documents to drive improvements in argument, style, tone, grammar, and adherence to formatting standards, all to improve accuracy and consistency. Desktop publishes content, adhering to MSI formatting and layout guidelines. Manages multiple projects with tight deadlines, prioritizing goals both independently and in collaboration with other teams and team members. Qualifications: Bachelor's degree. Given the nature of the team and the role, some professional experience in technical writing or creative writing is desirable, but not necessarily required. A solid understanding of mission critical technology in general and Motorola Solutions in particular is critical for this role. Demonstrated expertise in relationship building across teams is essential for success. Clear evidence of strong critical thinking skills, careful attention to detail, and persistent follow-through on job requirements strongly preferred. Target Base Salary Range: $65,900 - $131,800 USD Consistent with Motorola Solutions values and applicable law, we provide the following information to promote pay transparency and equity. Pay within this range varies and depends on job-related knowledge, skills, and experience. The actual offer will be based on the individual candidate. #LI-MM1 Basic Requirements Bachelor's degree. Travel Requirements None Relocation Provided None Position Type New Grad Referral Payment Plan No Our U.S. Benefits include: Incentive Bonus Plans Medical, Dental, Vision benefits 401K 10 Paid Holidays Generous Paid Time Off Packages Employee Stock Purchase Plan Paid Parental & Family Leave and more! EEO Statement Motorola Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other legally-protected characteristic. We are proud of our people-first and community-focused culture, empowering every Motorolan to be their most authentic self and to do their best work to deliver on the promise of a safer world. If you'd like to join our team but feel that you don't quite meet all of the preferred skills, we'd still love to hear why you think you'd be a great addition to our team. We're committed to providing an inclusive and accessible recruiting experience for candidates with disabilities, or other physical or mental health conditions. To request an accommodation, please complete this Reasonable Accommodations Form so we can assist you.

Posted today

Director Of Technical Documentation/Writing-logo
Director Of Technical Documentation/Writing
Anduril IndustriesCosta Mesa, CA
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduril is changing how military systems are designed, built and sold. Anduril's family of systems is powered by Lattice OS, an AI-powered operating system that turns thousands of data streams into a realtime, 3D command and control center. As the world enters an era of strategic competition, Anduril is committed to bringing cutting-edge autonomy, AI, computer vision, sensor fusion, and networking technology to the military in months, not years. ABOUT THE TEAM Anduril's Mission Success team is a cross-functional group that partners with every business line and supports all products that Anduril builds. Our responsibilities include product operations, training and adoption, and user documentation, and we sit within a broader team whose focus is on integrated product support. We are seeking an experienced Technical Documentation Director to lead a team to create and maintain user documentation across our diverse business lines. We believe that the quality of our documentation should reflect the quality of products, which are world-class. ABOUT THE ROLE As an experienced Technical Documentation Director, your mission is to lead our team in delivering exceptional, user-centric product documentation. In this role, you will design and deliver a forward-looking strategy, streamline documentation processes, and lead a team of technical writers, editors, and illustrators to produce content that meets both user needs and business objectives. You will partner with our numerous product and operations teams to deliver accurate, updated, and easy-to-understand documentation on how to use Anduril products. You will do whatever it takes to organize our engineering and program delivery functions in this mission. In this role, you will work closely with engineers, operations, and various subject matter experts to understand our products, identify user workflows, and use documentation to close the gap. As such, you will play a foundational role in setting the bar for tone, voice, and quality across our written artifacts. With Anduril's focus on defense and national security, user documentation plays a critical role in ensuring front-line operators know how to leverage the "arsenal of democracy." Your team's mission is to make the process of learning how to operate systems as easy and seamless as possible, with exceptionally well written and presented artifacts. You will supervise your team's efforts to identify relevant stakeholders and lead them through documentation roadmaps with established key milestones and targets. This will require an in-depth understanding of what teams are relevant to documentation, and what an organized effort toward collaboration entails. You are to ensure that stakeholders are engaged at the right time, and you will guide them towards a finished user-facing document that plainly meets customer needs. Finally, your team will work with account managers to ensure that contract deliverables are accurate, on-time, and in the right format. Written content artifacts under this charge may include things like: technical manuals, operational manuals, maintenance manuals, procedures, checklists, templates, user guides, troubleshooting guides, and release notes. You will partner with account, product, and engineering teams across all phases of product development to ensure users have the right documentation available. Along with our commercial offerings outlined above, Anduril is pursuing Programs with the US Government, which require documentation in MIL-STD-40051D, and S1000D, delivered via IADs. Familiarity with these standards is highly desired. WHAT YOU'LL DO Establish a comprehensive documentation strategy that aligns with product roadmaps, including scalable content architectures and clear style guides. Design and implement a streamlined documentation intake, review, and management workflow to support product release cycles. Implement performance metrics and key indicators to track documentation quality and success. Maintain high standards for clarity, consistency, and technical accuracy in all documentation. Identify high-priority areas for improvement in existing documentation, devising and executing actionable improvement plans. Generate, review, and edit documentation that is user-focused. Work with engineering and operations to deliver task, conditions, standard-centric documentation. Contribute to Anduril's technical writing toolkit - working on everything from style guides to the documentation lifecycle and review process, and also relevant software tool procurement through definition requirements for things like authoring and publishing tools. Evaluate and prioritize tasks required to successfully support product documentation efforts and keep them on track. Help drive the best decision for the company by using a data-driven approach and consider input from stakeholders to ensure well-informed decisions. You should be prepared to fill gaps that represent risks to the documentation roadmap. Communicate and help manage expectations. Ensure risks are noted with adequate time, mitigations are identified, and resources are allocated. Help build a culture of technical documentation by creating process and training for others to contribute content. Refine our product maturity framework so that documentation is a meaningful step towards productization of new systems. REQUIRED QUALIFICATIONS 8+ years of demonstrated excellence generating technical documentation. 3+ years of experience managing teams of technical writers, editors, illustrators, etc. Experience writing technical user-facing documentation. Experience reading and interpreting engineering documentation. Experience building content in a variety of content authoring tools including word editors and specialized authoring software (e.g. Oxygen Author, Raytheon Eagle, Siemens PLM, etc). Strong communication (written and verbal) and interpersonal skills, with emphasis on technical subjects. Must thrive with autonomy and responsibility, managing competing priorities and tight deadlines. Impeccable project-management skills. Passion for excellent documentation and user experience. Eligible to obtain and maintain an active U.S. Secret security clearance. PREFERRED QUALIFICATIONS Military exposure and experience, particularly with military technical documentation writing and formatting standards, guidelines, and verbiage (MIL-STD-40051, S1000D, etc). Previous experience creating technical documentation in Aerospace and Defense (for DoD). Experience delivering content on fast-paced, complex projects with multiple stakeholders. Ability to use data insights to refine and optimize content strategies. US Salary Range $190,000-$285,000 USD The salary range for this role is an estimate based on a wide range of compensation factors, inclusive of base salary only. Actual salary offer may vary based on (but not limited to) work experience, education and/or training, critical skills, and/or business considerations. Highly competitive equity grants are included in the majority of full time offers; and are considered part of Anduril's total compensation package. Additionally, Anduril offers top-tier benefits for full-time employees, including: Platinum Healthcare Benefits: For U.S. roles, we offer comprehensive medical, dental, and vision plans at little to no cost to you. For UK roles, Private Medical Insurance (PMI): Anduril will cover the full cost of the insurance premium for an employee and dependents. For AUS roles, Private health plan through Bupa: Coverage is fully subsidized by Anduril. Basic Life/AD&D and long-term disability insurance 100% covered by Anduril, plus the option to purchase additional life insurance for you and your dependents. Extremely generous company holiday calendar including a holiday hiatus in December, and highly competitive PTO plans. 16 weeks of paid Caregiver & Wellness Leave to care for a family member, bond with your baby, or tend to your own medical condition. Family Planning & Parenting Support: Fertility (eg, IVF, preservation), adoption, and gestational carrier coverage with additional benefits and resources to provide support from planning to parenting. Mental Health Resources: We provide free mental health resources 24/7 including therapy, life coaching, and more. Additional work-life services, such as free legal and financial support, available to you as well. A professional development stipend is available to all Andurilians. Daily Meals and Provisions: For many of our offices this means breakfast, lunch and fully stocked micro-kitchens. Company-funded commuter benefits available based on your region. Relocation assistance (depending on role eligibility). 401(k) retirement savings plan - both a traditional and Roth 401(k). (US roles only) The recruiter assigned to this role can share more information about the specific compensation and benefit details associated with this role during the hiring process. Anduril is an equal-opportunity employer committed to creating a diverse and inclusive workplace. The Anduril team is made up of incredibly talented and unique individuals, who together are disrupting industry norms by creating new paths towards the future of defense technology. All qualified applicants will be treated with respect and receive equal consideration for employment without regard to race, color, creed, religion, sex, gender identity, sexual orientation, national origin, disability, uniform service, Veteran status, age, or any other protected characteristic per federal, state, or local law, including those with a criminal history, in a manner consistent with the requirements of applicable state and local laws, including the CA Fair Chance Initiative for Hiring Ordinance. We actively encourage members of recognized minorities, women, Veterans, and those with disabilities to apply, and we work to create a welcoming and supportive environment for all applicants throughout the interview process. If you are someone passionate about working on problems that have a real-world impact, we'd love to hear from you! To view Anduril's candidate data privacy policy, please visit https://anduril.com/applicant-privacy-notice/ .

Posted 30+ days ago

Proposal Content (Writing) Manager-logo
Proposal Content (Writing) Manager
Motorola SolutionsLinthicum, MD
Company Overview At Motorola Solutions, we believe that everything starts with our people. We're a global close-knit community, united by the relentless pursuit to help keep people safer everywhere. Our critical communications, video security and command center technologies support public safety agencies and enterprises alike, enabling the coordination that's critical for safer communities, safer schools, safer hospitals and safer businesses. Connect with a career that matters, and help us build a safer future. Department Overview Motorola Solutions is a global leader in public safety and enterprise security. Our Proposal Center is an integrable part of the organization, helping sales teams deliver winning proposals. The Proposal Center is composed of State and Local solicited RFP teams, a Federal proposal group, plus Writing and Tools Teams. Job Description A Proposal Content (Writing) Manager plays an active role in developing and maintaining high-quality proposal content for use in both competitive and non-competitive proposals. This role works with Sales and Presale teams, Product Managers, and Marketing professionals to ensure the availability of clear, persuasive, compelling proposal content. Responsibilities of the Proposal Content Manager include but are not limited to: Works with Subject Matter Experts (SMEs) to review and update documents that explain how our solution(s) meet customer requirements, goals, and desires and crafts language to support our value proposition. Establishes and maintains relationships with SMEs, aimed at ensuring that all Standard Content Library documents are reviewed at least annually to determine if the documents are still valid and relevant as well as to update the documents so that they remain accurate and complete. Follows up relentlessly to ensure that reviews are completed in a timely fashion and updated documents are posted in the Standard Content Library. Executes, evaluates, and continually improves processes for contacting SMEs and requesting annual reviews. As part of the review process, checks all documents to drive improvements in argument, style, tone, grammar, and adherence to formatting standards, all to improve accuracy and consistency. Desktop publishes content, adhering to MSI formatting and layout guidelines. Manages multiple projects with tight deadlines, prioritizing goals both independently and in collaboration with other teams and team members. Qualifications: Bachelor's degree. Given the nature of the team and the role, some professional experience in technical writing or creative writing is desirable, but not necessarily required. A solid understanding of mission critical technology in general and Motorola Solutions in particular is critical for this role. Demonstrated expertise in relationship building across teams is essential for success. Clear evidence of strong critical thinking skills, careful attention to detail, and persistent follow-through on job requirements strongly preferred. Target Base Salary Range: $65,900 - $131,800 USD Consistent with Motorola Solutions values and applicable law, we provide the following information to promote pay transparency and equity. Pay within this range varies and depends on job-related knowledge, skills, and experience. The actual offer will be based on the individual candidate. #LI-MM1 Basic Requirements Bachelor's degree. Travel Requirements None Relocation Provided None Position Type New Grad Referral Payment Plan No Our U.S. Benefits include: Incentive Bonus Plans Medical, Dental, Vision benefits 401K 10 Paid Holidays Generous Paid Time Off Packages Employee Stock Purchase Plan Paid Parental & Family Leave and more! EEO Statement Motorola Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other legally-protected characteristic. We are proud of our people-first and community-focused culture, empowering every Motorolan to be their most authentic self and to do their best work to deliver on the promise of a safer world. If you'd like to join our team but feel that you don't quite meet all of the preferred skills, we'd still love to hear why you think you'd be a great addition to our team. We're committed to providing an inclusive and accessible recruiting experience for candidates with disabilities, or other physical or mental health conditions. To request an accommodation, please complete this Reasonable Accommodations Form so we can assist you.

Posted today

Director, Medical Writing-logo
Director, Medical Writing
Corcept TherapeuticsRedwood City, CA
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director, Medical Writing will collaborate with colleagues to write and/or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management Mentor and support direct reports in the development of their skills and careers Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, and other regulatory submissions as needed Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables Maintain subject area expertise related to the company's investigational products, disease indications, and regulatory and publication guidelines Perform miscellaneous job-related duties and additional duties and responsibilities as needed Preferred Skills, Qualifications and Technical Proficiencies: Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas Excellent attention to detail, multitasking, prioritization, and flexibility Excellent communication skills with proven ability to interact in a cross-functional environment Understanding of the drug-development process, including research and development processes and objectives and the required documents Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint) Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision Ability to think strategically, be resourceful, and lead without formal authority Preferred Education and Experience: BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $172,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Posted 30+ days ago

Senior Specialist, Technical Writing-logo
Senior Specialist, Technical Writing
Edwards Lifesciences CorpIrvine, CA
Job Description: Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Sr. Specialist, Technical Writer position is a unique career opportunity that could be your next step towards an exciting future. The Sr. Specialist, Technical Writing role will develop and create accurate Good Manufacturing Practices (GMP) technical documents. How you'll make an impact: Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes Maintain documentation in a standard format following established guidelines Review documents for style, clarity, grammar, and punctuation Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures Recommend improvements to current documentation practices and propose recommended changes May lead special projects (e.g implementation of new style of documentation procedures) Other duties assigned by Leadership; Provide guidance and training to lower level employees What you'll need (Required): Bachelor's Degree in related field and 5 years of technical writing experience OR Master's Degree in a related field and 3 years of technical writing experience What else we look for (Preferred): biotechnology industry (e.g., Quality Assurance, Regulatory) Proven expertise in Content Management Systems, topic-based authoring, and authoring using reusable content. Microsoft Office Suite including Word, Excel, PowerPoint, and Publisher; Adobe InDesign and Photoshop preferred. Experience with RWS Tridion Docs preferred Excellent editing and proofreading skills Excellent written and verbal communication skills in English including negotiating and relationship management skills Excellent problem-solving and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports) Excellent technical writing skills Full knowledge of product assembly procedures Ability to manage competing priorities in a fast paced environment Strict attention to detail Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $80,000 to $113,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Innovation Product Manager - Gene Writing & Editing (GWE)-logo
Innovation Product Manager - Gene Writing & Editing (GWE)
Integrated DNA TechnologiesCoralville, Iowa
Innovation Product Manager – GWE Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of the Gene Writing and Editing Business Unit and will be located on-site in Coralville, IA. This role’s focus will be on the CRISPR and Synthetic Biology markets. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things. In this role, you will have the opportunity to: Develop business cases to initiate investment or change in behavior to achieve long-term revenue and margin growth objectives in your target market. Maintain complete customer insights through qualitative/quantitative market research and robust customer relationships. Develop and communicate product insights, positioning, and value proposition throughout the organization creating alignment around the goals. Serve as a subject matter expert for product lines and target markets/customers with regular analysis of trends, competitors, channels, standards, etc. Collaborate with Commercial Product Management to support lifecycle management decisions including product obsolescence and discontinuation. The essential requirements of the job include: Bachelor's degree or equivalent in business, life sciences, engineering or similar disciplines Minimum 3 years of experience in Product Management or Commercial departments or equivalent function -- or in scientific / R&D in Gene Editing or highly-related technical background, 5 years of experience preferred. May accept less experience with MBA/MSc/PhD degree. Minimum of 2 years of experience within Life Sciences or related scientific industry. Experience in synthetic biology, functional genomics, or gene editing markets preferred. Demonstrated success defining and launching excellent products. It would be a plus if you also possess previous experience in: Knowledge of CRISPR editing systems and/or synthetic biology solutions Ability to work and influence all levels of the organization from Senior Leaders, Functional Leaders to project managers and practitioners in all functional areas and gain followership Excellent communication, interpersonal, organizational, and leadership skills Advanced degrees (MS, MBA) We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

Posted 30+ days ago

ICF Medical Writing Project Manager-logo
ICF Medical Writing Project Manager
Thermo Fisher ScientificBethesda, Maryland
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We have a vacancy for an ICF Medical Writing Senior Project Manager based in a number of global locations. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Informed Consent Forms (ICFs) and other critical documents, ensuring outstanding quality and compliance. A day in the Life: • Develop project timelines, standards, budgets, and forecasts. • Collaborate with cross-functional teams to meet deliverables. • Monitor timelines and provide status updates. • Identify and resolve client management issues. • Ensure compliance with quality processes. Keys to Success: • Proven project management skills. • Strong planning and organizational abilities. • Excellent interpersonal and communication skills. • Ability to work independently and under pressure. Education • BS/BA (preferred field of study: scientific) with at least 5 years of relevant experience, or an advanced degree with at least 3 years of relevant experience. Experience • Experience managing medical writing or clinical projects. • Pharmaceutical/CRO industry experience preferred. • Advantageous to have experience in regulatory and/or plain language medical writing. Knowledge, Skills, Abilities • Solid project management, budgeting, and forecasting skills. • Effective problem-solving and decision-making abilities. • Proficient in global and regional regulatory guidelines. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Compensation and Benefits The hourly pay range estimated for this position Medical Writing Lead based inMaryland is $85,000.00–$100,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Posted 5 days ago

Director, Proposal Writing-logo
Director, Proposal Writing
CCS FundraisingNew York, New York
Description TITLE: Director, Proposal Writing LOCATION: New York, New Jersey, Connecticut REPORTS TO: Senior Director, Proposal Writer TYPE: Full Time, Remote (with occasional one to two days in-office a week) Please submit a cover letter. This position is not eligible for employer visa sponsorship. WHO WE ARE CCS Fundraising is an international strategic fundraising firm that partners with nonprofits for transformational change. Since 1947, CCS has empowered many of the world’s greatest organizations across sectors to advance some of the most important causes in history. We plan, manage, and implement programs and initiatives that achieve fundraising goals and mission impact. CCS provides tailored support to more than 700 nonprofit organizations annually. Headquartered in New York, the firm has over 600 professionals and 18 offices throughout the United States and Europe. Our people are our greatest strength. At CCS, you will join a diverse team of smart, passionate, and resourceful professionals who are driven by purpose and committed to performance. UNDERSTANDING THE ROLE CCS is seeking a motivated, deadline-driven Director, Proposal Writing to work with a New York-based Executive team. The successful candidate will work closely with our Executive team, managing new leads from ideation to contract and ensuring that all team Executives have the materials and preparation they need to conduct successful business development and sales meetings. A critical component of this role is to produce compelling, consistent, creative, and professional proposals, RFPs, and presentations that differentiate CCS from our competitors. Please note that this is not a sales or lead generating position. Ideal candidates will possess excellent writing, communication, research, and design skills to contribute to the development of sales materials and resources. The candidate is also comfortable working with multiple Executives and other proposal writers and is capable of meeting set deadlines and prioritizing tasks in a fast-paced corporate environment. Prior experience with RFPs, proposals, and client relationship management databases are a plus. Experience with research, data visualization, and professional writing is key. This is an excellent opportunity to join a growing team in a role that has room to grow and evolve. RESPONSIBILITIES Write and design customized sales proposals, presentations, and supporting materials in close coordination with the Executive Team Participate in sales meetings as needed to understand client needs and inform proposal strategy Develop tailored content based on the specific needs, scope, and interests of each prospective client Partner with Team Executives to define key elements of each proposal, including scope of work, pricing, and service structure Establish and manage internal timelines to guide daily work and ensure on-time delivery of materials Collaborate with the Executive Team to identify strategic next steps for active leads in the sales pipeline Support final editing, formatting, and distribution of proposals and other materials Complete research on potential leads and complete other sales materials in advance of sales meetings to ensure Team Executives are prepared in a timely manner Maintain and update proposal templates; customize templates as needed for specific proposals, decks, one-pagers, etc. Assist other proposal writers in securing client case studies and references for proposals Draft thank-you and follow-up correspondence for Team Executives Work with team database coordinators to ensure our information is up-to-date Liaise with proposal writers across the firm to understand trends and continually enhance materials Additional tasks as needed to support the sales process QUALIFICATIONS Bachelor’s degree required 3+ years professional experience with proven writing and project management track record Exceptional ability to manage multiple projects and competing deadlines in a fast-paced environment Excellent writing and visualization skills, with a keen eye for detail Thorough proofreading skills Excellent time management and organizational abilities; capable of independently structuring time and tasks to meet deadlines Demonstrated resourcefulness and initiative in problem-solving and adapting to changing needs Advanced knowledge of Word, Excel, PowerPoint, and Outlook Creative presentation design experience - experience with InDesign, Photoshop, Publisher, Canva, and other graphic design programs a plus but not required Comfortable working both independently and collaboratively within a team setting CCS offers competitive benefits, a dynamic training program, resources, career advancement, mentoring, and networking opportunities. We are an Equal Opportunity Employer and strongly encourage a diverse pool of candidates to apply. SALARY RANGE: $60,000 - $90,000 The exact salary varies within range based on years of relevant experience and education.

Posted 4 days ago

CAS- Full-Time Lecturer - Department of Writing Studies-logo
CAS- Full-Time Lecturer - Department of Writing Studies
AcademyCoral Gables, Florida
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet . The Department of Writing Studies at the University of Miami is accepting applications for full-time lecturer positions with an expected start date of August 15, 2025. The normal teaching assignment is four courses each semester. With permission of the chair, Lecturers may also choose to substitute one course per semester for consulting 10 hours per week in the University’s Writing Center. Initial appointment(s) are for one year and may be renewable depending on enrollments and the university budget. We encourage applications from candidates with an interest in or experience with professional writing, grant writing, legal and policy writing, artificial intelligence, and data visualization. In addition to housing a vibrant and richly diverse first-year writing program, the Department regularly offers courses in professional writing, legal writing, STEM, and civic and community engagement. As well, the department has a Minor in Professional Writing and a new Writing-Enriched Curriculum initiative. Application materials should include: A cover letter describing your background and experience A curriculum vitae A list of 3 professional references Applicants must hold a PhD, MFA, or JD (or equivalent terminal degree) with a background in Writing Studies, Rhetoric and Composition, English, Professional and/or Technical Communication, or a closely related field, by the start date of the appointment. For consideration, applicants must submit their application materials, assembled as a single PDF file, to the University of Miami’s Career Opportunities website, located at: https://umiami.wd1.myworkdayjobs.com/UMFaculty . Review of applications will begin immediately and will continue until the positions are filled. Inquiries and requests for information can be sent to Dr. Ben Lauren, Chair of the Department of Writing Studies: blauren@miami.edu . The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Faculty

Posted 30+ days ago

Affiliated Faculty Member | Writing, Literature and Publishing-logo
Affiliated Faculty Member | Writing, Literature and Publishing
Emerson CollegeBoston, Massachusetts
Join our community and experience Emerson College! The Department of Writing, Literature, and Publishing is a vibrant and engaged community of writers, scholars, publishers, and designers. The department has over 120 full- and part-time faculty members, nearly 500 undergraduate majors, and over 330 graduate students in the Creative Writing MFA program, the online MFA program in Popular Writing and Publishing, and the Publishing MA program. Responsibilities: Teach assigned courses and/or duties as specified in the schedule and contract Select texts and instructional materials; prepare course materials and lesson plans Provide students an approved syllabus that includes course description, learning objectives, course calendar, course requirements, texts, and other materials, grading policy and the required accessibility and plagiarism statements Be available for student consultation through office hours or scheduled appointments or by phone or email Maintain records of enrollment and attendance, assessments and grades, submit class rosters and grades online by the deadlines established by the College Upload your CV.

Posted 30+ days ago

Part Time Writing Center Tutor-logo
Part Time Writing Center Tutor
Ivy Tech Community CollegeFort Wayne, IN
Provide individual and group tutoring virtually and in-person in a manner that enhances student success. Primary focus will be on tutoring for Freshman Composition courses. Major Responsibilities: Will be working on-campus. Maintain a functional and productive tutoring environment. Interact with faculty as to student needs, course changes and writing strategies. Monitor student activity logs and internet sites accessed. Assist students with Canvas, MicroSoft Office, and other software programs. In addition to the above, other duties associated with working in the Writing Center may be assigned. Minimum Qualifications: Credentialed to teach ENGL 111: English Composition: "A qualified faculty member in English meets the discipline standard through one of two routes: Possesses an earned master's or higher degree from a regionally accredited institution in English, or Possesses an earned master's or higher degree from a regionally accredited institution in any field with 18 graduate semester credit hours in English, linguistics, or courses related to the writing process" (ASOM 07.01.00) Must provide cover letter and transcripts with application Preferred Qualifications: The Minimum Qualifications and Tutoring or teaching experience at the college level. Other Requirements: Selected candidate for employment will be subject to pre-employment background checks, including criminal history check, and any offer of employment will be contingent upon that outcome. Transcripts due at the time of hire. Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College's Title IX Coordinator or to the US Department of Education Office of Civil Rights.

Posted 30+ days ago

Senior Manager, Medical Writing-logo
Senior Manager, Medical Writing
Gilead Sciences, Inc.Parsippany, NJ
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description POSITION OVERVIEW: Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world. We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Inflammation) to join our dynamic team. You will author a wide range of regulatory documents independently, including documents of high complexity. You will lead review and planning processes for multiple products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements, new standards, and updating document templates. You may coach, train, and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise contractors to ensure the highest quality of medical writing and adherence to Gilead documents standards. EXAMPLE RESPONSIBILITIES: Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses. May represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent. Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects. May serve as the filing lead for small to medium regulatory submissions. May serve as lead medical writer and department representative across development programs. Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities. May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives. Where applicable, oversees the work of external contractors supporting deliverables and other activities. May coach, train, and provide guidance to less experienced Medical Writing colleagues. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. U.S. Education & Experience PharmD/PhD with 4+ years' relevant experience. MA/MS/MPH/MBA with 6+ years' relevant experience. BA/BS with 8+ years' relevant experience. Significant medical writing, regulatory, quality, clinical R&D, or related experience supporting medicinal products. Significant experience in the biopharma industry is strongly preferred. Experience authoring a broad range of regulatory, scientific, and/or medical documentation across multiple stages of drug development. Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred. Rest of World Education & Experience BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry. Knowledge & Other Requirements Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance. In-depth knowledge of relevant health authorities, including system, processes and requirements. In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation. Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives. Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles. Ability to lead and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly matrixed environment. When needed, ability to travel. The salary range for this position is: Other US Locations: $157,590.00 - $203,940.00. Bay Area: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 1 day ago

US Quintiles logo
Associate Director, Medical Writing
US QuintilesDurham, North Carolina
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Job Description

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development.

As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency

This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions

  • This role reports to the Director of Medical Writing
  • Senior Medical Writer(s) and Medical Writer(s) will report to this role

Main Responsibilities and Accountabilities

  • Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities:
  • Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives
  • Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed.
  • Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission)
  • The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
  • Forecasting, budgeting, resource planning and resource allocation.
  • Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work

Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development

  • Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).

  • Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
  • Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
  • Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
  • Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
  • Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data
  • Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
  • Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.

  •  Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
  • Responsible for continual improvement of in-house medical writing.
  • Provides expert medical writing support to other CR&D and CSL groups where required
  • In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
  • Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance.
  • Participant in bid defense, contract development, work alignment and / or operation meetings.
  • Post-graduate qualifications (PhD or MD preferred)

Experience

  • A minimum of 8 years medical writing experience within the biopharmaceutical
  • industry or a contract research organization.
  • A minimum of 3 years in a supervisory role
  • A comprehensive understanding of the clinical development process, including the
  • documents that are required at each stage.
  • A comprehensive understanding of medical writing processes, standards and issues.
  • Demonstrated track record in cross-functional, multicultural and international clinical trial teams
  • Excellent verbal, written and presentation skills.
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Prior experience with submissions in Common Technical Document (CTD) format.
  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status