MedZilla

ExecuPharm is a Global Functional Service Contract Research Organization, certified by the Women’s Business Enterprise National Council (WBENC), who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

Position Purpose: The Medical Writer (MW) is responsible for development of medical writing deliverables that support the Client’s clinical regulatory writing portfolio. The MW works with minimal guidance and oversight to achieve goals, and is expected to be well experienced in clinical regulatory writing. Experience writing patient narratives, Investigator brochures, clinical study reports, protocols and protocol amendments as well as other regulatory documents.

Training and Education:

• Bachelor’s degree in Life Sciences with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.
• 3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
• Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
• Participate actively in medical writing and cross-functional project teams.
• 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.
• Awareness of pharmaceutical industry needs beyond clinical development.

ExecuPharm's client is a major pharmaceutical company. This position is a work-from-home position.

Salary range is 120-145K, depending on experience plus paid time off and a full benefits package.