Associate Director Medical Writer- REMOTE

Biotech focusing on rare disease is hiring an AD Clinical Medical Writer - REMOTE

Will be responsible for the complete preparation, including but not limited to, the writing, reviewing, and editing of Protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Summary Modules for regulatory submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems. He/she is responsible for leading all medical writing activities of a clinical development program.

• This is a supervisory position (1 to 2 direct/in-direct reports)
• This role oversees vendors and/or contractors

Responsibilities

• Acts as the lead medical writer and responsible for the complete preparation of all documents for assigned clinical development programs. Performs hands-on authoring of critical documents.
• Provides leadership/ document strategy at the program level. Plan and negotiate timelines.
• Critically reviews documents produced by internal and external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
• Serves as a subject matter expert, representing Medical Writing on cross-functional teams.
• Participates in appropriate development teams and internal strategy and operations meetings.

Qualifications

• BA/BS with minimum 7 years (or advanced degree with minimum 4 years) of writing experience in the biopharma industry across therapeutic areas required; advanced degree preferred
• Progressive experience in medical writing, including oversight/management of permanent and contract staff or CROs
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
• Successful track record of leading complex clinical / regulatory writing projects

SDL2017