Senior Manager, Medical Writing

This is a fully remote position, open to applicants in California.

📋 Description

• Prepares and evaluates clinical/regulatory documentation to facilitate all stages of drug development.

• Oversees the writing processes associated with all regulatory documents for a project team.

• Identifies and manages external contractors.

• Plans activities related to New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs).

• Develops and oversees the submission writing team.

• Authors and supervises the authoring process for all clinical/regulatory documentation.

• Leads and offers subject matter expertise to the core authoring team.

• Ensures that document content is clear, concise, strategic, and well-prepared for public disclosure.

• Promotes authoring best practices and provides ongoing training to teams.

• Represents the Medical Writing Department on project teams.

• Mentors and may supervise internal staff.

⛳️ Requirements

• A BS/BA degree in life sciences or a related field with 8+ years of medical writing or relevant experience is required.

• Proven experience in leading an NDA/MAA or authoring key documents that support either process.

• An MS/MA degree in life sciences or related field is preferred, along with 6+ years of the aforementioned experience.

• A PhD in life sciences or a related field is preferred, accompanied by 4+ years of the noted experience.

• Prior managerial or functional management experience is also essential.

• A strong team player capable of effectively navigating diverse opinions and personalities.

• Excellent leadership, communication, and creative skills.

• Outstanding project management abilities, including the management of multiple simultaneous projects.

• Proficient understanding of Microsoft Word and PowerPoint, document management systems, and electronic review tools.

• General knowledge of statistics.

• Comprehensive understanding of medical writing processes, procedures, and systems.

🏝️ Benefits

• Retirement savings plan (with company match).

• Paid vacation.

• Holiday and personal days.

• Paid caregiver/parental and medical leave.

• Health benefits, including medical, prescription drug, dental, and vision coverage.