Director, Medical Writing

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

📋 Description

• Provides strategic and operational guidance for the Medical Writing function.

• Responsible for the planning, development, and delivery of high-quality clinical and regulatory documentation.

• Acts as a strategic ally to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders.

• Tasked with establishing medical writing standards, enhancing organizational capabilities, and ensuring the execution of medical writing activities across the portfolio.

• Develops and implements the Medical Writing functional strategy in alignment with corporate and development goals.

• Oversees Medical Writing resource planning, including internal staffing, contractor supervision, and vendor management strategies.

• Establishes and upholds governance, standards, templates, and quality processes for Medical Writing.

⛳️ Requirements

• A Bachelor's degree in Life Sciences or a related field is required; an advanced degree (PhD, PharmD, MD, or Master's degree) is preferred.

• At least 12 years of experience in the biopharmaceutical sector, with a minimum of 10 years in progressive medical writing roles.

• At least 3 years of experience in people leadership or functional management.

• Proven track record in leading Medical Writing activities for complex global regulatory submissions, including INDs, NDAs, BLAs, and MAAs.

• Extensive knowledge of the clinical trial document lifecycle, including protocols, Investigator's Brochures, Clinical Study Reports, CTD summaries, and health authority briefing documents.

• In-depth understanding of global regulatory standards and guidelines, such as FDA, EMA, ICH, and GCP.

• Demonstrated experience in building and managing medical writing teams, contractors, and external vendors.

• Proven ability to autonomously lead in a fast-paced, dynamic, and highly collaborative biotechnology setting.

• Strong skills in strategic thinking, organization, and project leadership.

• Exceptional written and verbal communication abilities, with the capacity to influence at all organizational levels.

• Proficient in standard business applications and industry systems, including Microsoft Office, Adobe Acrobat, SharePoint, Veeva RIM, EndNote, and related document management platforms.

🏝️ Benefits

• Comprehensive health benefits

• Annual performance bonus

• Company equity