Executive Director, Medical Writing - California, United States - Meet

Description

Executive Director of Medical Writing

Company Overview:

We are partnered with a pioneering biotech company dedicated to addressing unmet medical needs in the field of rare diseases. With a commitment to innovation and patient-centric solutions, they strive to make a significant impact on the lives of those affected by rare diseases.

Location: San Francisco Bay Area, California

Position Overview:

They are seeking a highly skilled and experienced Executive Director of Medical Writing to join their dynamic team. This individual will play a crucial role in leading and overseeing the medical writing activities for our rare disease programs. The position requires three days per week on-site to ensure effective collaboration and project management.

Key Responsibilities:

• Lead and manage the medical writing team in the planning, development, and delivery of high-quality regulatory documents, including but not limited to clinical study reports, protocols, investigator brochures, and submission documents.
• Serve as the primary point of contact for medical writing activities, collaborating closely with cross-functional teams including Clinical Development, Regulatory Affairs, and Research & Development.
• Develop and implement medical writing strategies, ensuring compliance with regulatory guidelines and industry standards.
• Provide guidance and mentorship to the medical writing team, fostering professional growth and maintaining a high standard of performance.
• Oversee the preparation and submission of regulatory documents to health authorities, contributing to the successful approval of investigational and marketing applications.
• Collaborate with external partners, including CROs and consultants, to support medical writing activities as needed.

Qualifications:

• Advanced degree in life sciences or related field.
• Extensive experience (minimum 10 years) in medical writing within the biotech/pharmaceutical industry, with a focus on rare diseases.
• Proven track record of successfully leading and managing a team of medical writers.
• In-depth knowledge of regulatory requirements (FDA, EMA, etc.) and experience in regulatory submissions.
• Excellent communication and interpersonal skills with the ability to collaborate effectively in a cross-functional environment.
• Strong project management abilities and the capacity to work in a fast-paced, deadline-driven environment.
• Flexibility to work on-site three days per week in the Bay Area.