Location: Raleigh-Durham, NC
Major Pharmaceutical company with strong oncology pipeline seeks Principal and Manager Medical writers to join their growing department. For candidates based in TN, GA, SC, NC – this can be a remote, work from home, staff position. For Candidates based in NJ, PA or Boston – this will be an in-office role with some work from home flexibility.
– Serve as a significant scientific contributor and subject matter expert in preparation and production of high quality and timely regulatory documentation.
– Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support ONCOLOGY pipeline projects (early to late phase).
– Represent functional area in cross-functional teams.
– Interpret and apply knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
– Lead and manage medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development (e.g., program level standards), trials (e.g., CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results.
– Solve complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
– Oversee the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provide feedback to their managers on development plans and performance reviews.
– Provide leadership for medical writing processes, standards, and innovative initiatives.
– Bachelor’s Degree in the Life Sciences w/10 years as a medical writer in the pharmaceutical and/or biotech industry OR MS with 8 years or PHD with 6 years. Add 2 yrs for Mgr.
– At Principal level, ability to prepare, without supervision, core clinical regulatory documents; at Manager level, ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD).
– Oncology experience preferred.
– Provide leadership of and management for complex documentation projects and project teams of medical writers.
– Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
– Excellent oral (including presentation) and written communication, and project management skills.
ABOUT THE COMPANY:
The company is major pharmaceutical with a strong oncology pipeline. Excellent compensation, target bonus, stock offered. Candidates must have oncology experience. Candidates based in NC, SC, TN and GA may work remotely. Candidates based in NJ, PA & Boston will work onsite with some work from home flex.