Director, Regulatory Writing

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

📋 Description

• Oversee the planning and management of regulatory submission elements from preclinical stages through to registration phases.

• Draft or coordinate clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, requests for health authority meetings and briefing documents, as well as summary documents for IND, CTA, CTR, and NDA.

• Manage external resources while facilitating communication with internal contributors and stakeholders.

• Act as the lead author and/or subject matter expert for essential deliverables.

• Represent Regulatory Writing on cross-functional teams alongside subject matter experts, Regulatory Affairs, and Program Management.

• Develop, sustain, and enhance SOPs, authoring guidelines, and project management tools.

• Assist with submission-related tasks in collaboration with Regulatory Affairs.

• Foster relationships with Regulatory colleagues, cross-functional project teams, and external stakeholders to meet timelines and achieve portfolio deliverables.

⛳️ Requirements

• BS or MS with a minimum of 7 years of progressively responsible experience as a regulatory/medical writer.

• A background in a scientific discipline is advantageous.

• Proven experience in medical writing within the pharmaceutical, biotech, or CRO sectors, particularly in the creation and updating of clinical development documentation.

• Experience in managing external resources is an asset.

• Proficient in Microsoft Word and knowledgeable about eCTD-compliant formatting standards.

• Skilled in organizing and interpreting intricate scientific and clinical data.

• Strong understanding of ICH, GCP, and FDA regulatory standards that govern regulatory documentation.

• Experience with rare diseases, pediatrics, genetic therapies, or expedited development pathways is highly preferred.

• Familiarity with Duchenne muscular dystrophy or neuromuscular therapeutic areas is beneficial.

• Exceptional project management abilities and the capacity to handle multiple projects under tight deadlines.

• Strong work ethic, excellent communication skills, a collaborative mindset, proactive work style, results-driven approach, integrity, a desire for continuous learning and growth, and a commitment to excellence.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Life and disability coverage.

• 401(k) matching program.

• Paid, gender-inclusive parental leave.

• Holistic support for overall health and well-being.

• Education reimbursement opportunities.

• Discretionary time off.

• Commuting benefits that align with the working model.