In the role of the Principal Medical Writer:

• Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional team (either internally or externally).
• Demonstrate competence in writing, editing, and reviewing Meeting Packages, Registration Dossier Modules, and other clinical regulatory documents per company and other guidelines.
• Interpret data and applies knowledge of regulatory/compliance/scientific requirements to document preparation.
• Manage medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.
• Produce high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
• Solve complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.

Work Experience:

Minimum education required:

• Degree in a life science, preferably related to pharmacy or medicine.
• Bachelor’s degree with 3 years; MS with 2 years; or with 1 years of relevant career experience.

Required Experience:

• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents in a clear, concise format in keeping with industry guidelines.
• Demonstrated participation in medical writing, document, and project teams.
• Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred.