Principal Medical Writer
Write and edit high-quality, medically relevant scientific publications (eg, clinical manuscripts, abstracts, posters, and oral presentations) for clinical pharmacokinetics teams across all therapeutic areas/assets to fulfill the medical/scientific objectives of the publication plan. Work together with the authors to manage the development, review, approval, and submission of publications according to agreed-upon timelines. Communicate effectively with external authors and internal stakeholders to drive projects to completion in a timely manner. Key responsibilities Include:
- Provide scientific publications writing/editing support to clinical pharmacokinetics teams, ensuring successful preparation of high-quality submission/presentation-ready documents at the direction of publication authors. Provide medical writing support for multiple assets across all therapeutic areas. Provide leadership and expertise on more complex topics/publications.
- Execute all activities related to the preparation of scientific publications (eg, clinical manuscripts, abstracts, posters, and oral presentations). Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects.
- Interface with external experts (eg, physicians, other health care professionals) and staff from other functions (eg, Clinical, Statistics, Medical Affairs,) to resolve conflicting comments and ensure accurate and timely completion of scientific publications.
- Communicate deliverables needed, writing process, and timelines to team members. Provide direction and guidance to junior and external medical writers, as assigned, ensuring high-quality and timely work products and adherence to publications policies and procedures.
- Learn and apply knowledge of therapeutic areas and assets to scientific publishing projects. Perform literature searches, as needed, for drafting publication content. Interpret literature information and make recommendations for application to scientific publications.
- Understand, assimilate, and interpret sources of information with appropriate guidance/direction from authors. Interpret and explain data generated from a variety of sources, including internal and external studies, regulatory submission documents, research documentation, and charts, graphs, and tables, and verify that results are consistent with study data. Convert relevant data and information into a form that meets publication needs and journal/congress requirements, ensuring required documentation is obtained.
- Explain data in a manner consistent with the target audience of the journal or congress. Confirm completeness of information to be presented. Understand/comply with appropriate guidances, conventions, proper grammar usage, and correct format requirements per journal/congress guidelines, and follow applicable company publication policy and procedures.
- Identify and propose solutions to resolve issues and questions arising during the writing/review process. Challenge conclusions when necessary. Independently resolve document content issues and questions. Gather feedback from others and revise drafts accordingly.
- Act as a subject matter expert regarding internal processes and publications best practices. Learn and apply knowledge of therapeutic area to scientific publishing projects within and across compounds. Mentor and provide guidance to more junior medical writers or external vendors/agencies.
- Contribute to department initiatives/activities to improve publications practices and processes. Stay current on industry and company requirements and best practices as they relate to scientific publications.
- Bachelor's degree required. MS/PhD/PharmD preferred. Professional credentials/certification (eg, AMWA) a plus.
- 4+ years of medical/scientific writing experience in the pharmaceutical/healthcare industry, academia, or other relevant industry.
- Expert knowledge of US and international regulations, requirements, and guidances associated with scientific publications.
- Excellent communication skills and attention to detail; ability to assimilate and interpret scientific content and translate information for appropriate audiences.
- Knowledge of pharmacokinetics and statistical concepts preferred.
- Excellent working knowledge of software programs (MS Office, Endnote, SigmaPlot, Adobe Acrobat, etc.), electronic document storage systems, and literature search engines/databases.
- Experience working in collaborative, cross-functional team environments; strong project management skills.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled