Executive Director, Medical Writing

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

📋 Description

• Direct the Medical Writing department, focusing on its strategic vision, operational framework, and capabilities.

• Establish departmental objectives and operational priorities that align with the goals of the organization and Regulatory Affairs.

• Serve as a representative of Medical Writing on cross-functional governance bodies and project teams.

• Cultivate a high-performing team that supports clinical development, regulatory submissions, and commercialization efforts.

• Supervise the planning, creation, review, and delivery of intricate regulatory and scientific documents throughout the product lifecycle.

• Formulate integrated document strategies that support global submission goals.

• Offer scientific and regulatory insights on content creation, messaging, and readiness for submission.

• Ensure that all documents comply with regulatory standards and meet company quality benchmarks.

• Collaborate with senior leaders to pinpoint documentation requirements and potential execution risks.

• Influence submission strategies, resource needs, timelines, and regulatory deliverables.

• Address complex challenges that may impact documentation quality, timelines, or readiness for submission.

• Act as a representative for Medical Writing during regulatory inspections, due diligence processes, and partner engagements.

• Recruit, nurture, and retain a high-performing Medical Writing team.

• Create the organizational structure, workforce plans, and succession strategies.

• Mentor and develop functional leaders.

• Establish departmental processes, standards, templates, metrics, and governance structures.

• Lead resource planning and capacity management for both internal staff and external partners.

• Manage the departmental budget and vendor strategy.

• Promote continuous improvement in quality, efficiency, scalability, and regulatory compliance.

⛳️ Requirements

• An advanced degree in life sciences, pharmacy, medicine, or a related field is preferred (PhD, PharmD, MD, or equivalent).

• Over 12 years of progressive experience in medical writing within the biotechnology or pharmaceutical sector.

• Extensive leadership experience.

• Proven track record in steering Medical Writing teams that support global clinical development and regulatory submissions.

• In-depth knowledge of FDA, EMA, and ICH regulatory requirements and guidelines throughout the product lifecycle.

• Experience in supporting INDs, BLAs, MAAs, and lifecycle management activities.

• Capability to influence cross-functional decision-making and foster collaborative relationships across senior leadership teams.

• Experience in developing organizational capabilities, leading change initiatives, and scaling teams in a growing organization.

• Strong executive communication, leadership, and interpersonal abilities.

• Proficiency in managing multiple complex projects while balancing strategic goals with operational execution.

• Preference for West Coast hours for remote work.

🏝️ Benefits

• Eligibility for bonuses.

• Comprehensive benefits package.

• Opportunity to participate in the Company’s stock plan.