As a Principal Medical Writer, you will collaborate with members of cross-functional teams to prepare (or oversee preparation by contract service providers) high-quality protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines.
Key Essential Functions:
- Prepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA submissions, other regulatory documents and related scientific documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
- Participates in scientific communication planning, including development of strategic medical communication plans
- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Manages all aspects of outsourced or internal deliverable production and ensures project delivery
- Partners with other clinical team members including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
- Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
- Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
- Works closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
- Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
- Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
- Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
- Support proactively in trainings & department operation activities as needed.
- Required Skills & Abilities:
- Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA/other regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
- Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details
- Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
- Ability to communicate scientific or medical information in a clear and concise manner
- Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
- Excellent organization skills with acute attention to detail
- Strong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activities
Required Qualifications:
- Bachelor’s degree +12 years, Master’s Degree +7 years, Doctoral Degree +5 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred.
- Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence and documents, and/or NDAs/BLAs, and peer-reviewed journal articles.