Principal Medical Writer

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 maintain 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.
• Showcases flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
• Conducts client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
• Acts as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
• Supports 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.

Working Conditions: Sedentary work that primarily involves sitting/standing. This can be a remote (USA) or office-based role.