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Director, Medical Writing

Aimmune Therapeutics

$211,990.00 per year

Full-time

320 Valley Dr

Brisbane, CA 94005

The Director, Medical Writing will be responsible for overseeing the development and finalization of key clinical and regulatory documents across therapeutic areas and throughout the product lifecycle.

Specific Responsibilities:

Lead and contribute to the development of clinical and regulatory documents such as clinical protocols, clinical study reports, investigator brochures, DSURs, briefing packages, INDs and amendments, BLA/MAA documents, and regulatory responses according to company standards, processes, and timelines

Participate on cross-functional teams and collaborate with team members to develop strategy and finalize project timelines

Identify resources for projects; recruit/oversee consultants as needed

Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance

Mentor junior medical writers, editors, and other team members

Critically review project work and training materials/guidelines generated by team members

Coordinate with Regulatory Science Information to execute scientific review processes.

Lead SOP development and review; implement work process improvements

Keep up-to-date with professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.

Other duties as assigned

Qualifications / Requirements:

Bachelor s degree in a science discipline or healthcare-related field. Advanced degree strongly preferred

10+ years of experience as a clinical/regulatory writer within the biotechnology or pharmaceutical industry required; freelance or closely related experience may be taken into consideration

5+ years of manager experience

Expert knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards

Expert skills in researching, writing, editing, reviewing, and managing clinical and scientific content

Able to manage multiple projects in a fast-paced environment with challenging deadlines and rapidly changing priorities

Good judgment and willingness to adapt working style and work product as required while adhering to quality standards

Record of collaborative multidisciplinary teamwork and problem solving; help facilitate cross-functional team agreement and complete projects without authority

Highly proficient in organization and project management skills

Expert knowledge of AMA style, medical terminology, and clinical data analysis

Expert knowledge and skills using Microsoft Word to generate complex document

Exceptional attention to detail, goal-oriented with assigned tasks, and self-motivated

PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Strong team-building skills

Excellent interpersonal and influencing skills; ability to negotiate well and build good relationships with coworkers

Professional and friendly demeanor, flexible, accommodating

Preferred Experience, Special Skills, Knowledge:

AMWA member with certificate a plus

BELS certification a plus


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