Principal Medical Writer - Immunology
The Principal Medical Writer is responsible for providing clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (eg. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions. Serves as the scientific writing content expert for the department.
- Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
- Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects.
- Serves as a department representative on project teams.
- Communicates deliverables needed, writing process, and timelines to team members.
- Converts relevant data and information into a form that meets clinical regulatory document requirements.
- Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines.
- Assesses resource needs as timelines progress and communicates those needs to department management.
- Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors. Ensures required documentation is obtained.
- Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.
- Explains data in manner consistent with clinical regulatory requirements.
- Confirms completeness of information to be presented. Challenges conclusions when necessary.
- Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
- Arranges and conducts review meetings with the team.
- Independently resolves document content issues and questions arising during the writing process.
- Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
- Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments.
- Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions.
- Recommends, leads, and implements tactical process improvements.
- Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with Regulatory on document strategies.
- Minimum of Bachelor's Degree required. PhD, PharmD, Master's Degree preferred. Relevant professional certification/credential (eg, CMPP, AMWA) is a plus.
- 4 years of medical/scientific writing experience in the pharmaceutical/health care industry, academia, or related experience (eg, medical communication agency, clinical/scientific research) required.
- Expert knowledge of US and international regulations, requirements, and guidances associated with scientific publications, and ability to advise teams regarding compliance with regulations, requirements, and guidances.
- High-level content writing experience, as well as experience with all types of clinical publications required.
- Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
- Working knowledge of statistical concepts and techniques required.
- Excellent written and oral communication skills. Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. Microsoft Office and Internet navigation proficiencies essential. Working knowledge of Datavision publication management system is a plus.
- Extensive experience in working with collaborative, cross-functional teams, including project management experience. Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance. Excellent business communication skills.
- Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality. Learns fast, grasps the "essence" and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo.