Principal Medical Writer

Summary

Join our team as a Principal Medical Writer and collaborate with cross-functional teams to create high-quality clinical documents. You will prepare or oversee the preparation of protocols, study reports, regulatory documents, and publications. Key responsibilities include managing document review, overseeing outsourced production, and collaborating with clinicians and scientists. You will ensure compliance with ICH guidelines and maintain standard operating procedures. The ideal candidate possesses extensive medical writing experience in the pharmaceutical industry, particularly in oncology, and a strong understanding of clinical research and regulations. This role requires excellent communication, organizational, and project management skills.

Requirements

• 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
• Have broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
• Be able 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; be attentive to details
• Be able 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
• Have excellent interpersonal, active listening, and influencing skills; establish and maintain professional and productive working relationships with team members
• Be able to communicate scientific or medical information in a clear and concise manner
• Have a track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
• Have excellent organization skills with acute attention to detail
• Have strong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activities
• Have a 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
• Have 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

Responsibilities

• Prepare, edit, and finalize 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
• Participate in scientific communication planning, including development of strategic medical communication plans
• Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
• Manage all aspects of outsourced or internal deliverable production and ensure project delivery
• Partner 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
• Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborate 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
• Ensure that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Work closely with QA to maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend 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

Preferred Qualifications

Have a graduate degree (masters or doctoral)