Director, Medical & Regulatory Writing

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

📋 Description

• Act as a subject matter expert in the creation of clinical regulatory documents throughout all phases of clinical research.

• Offer strategic guidance on document preparation for intricate regulatory submissions, including IND and NDA/BLA applications.

• Represent medical writing during cross-functional team meetings.

• Work collaboratively with clinical research, operations, data management, biostatistics, regulatory affairs, and medical affairs teams to produce high-quality documents within deadlines.

• Comply with ICH-E3 guidelines, federal regulations, and company standard operating procedures (SOPs).

• Create, enhance, and maintain medical writing work practice documents, SOPs, and document templates.

• Oversee external vendors, including contract writers, quality control reviewers, and document formatters.

• Keep abreast of industry trends and best practices in medical writing.

• Organize and manage document timelines efficiently.

• Execute other assigned responsibilities.

⛳️ Requirements

• A Bachelor’s, Master’s, or PhD degree in a scientific, medical, clinical discipline, or a related field is essential; a Master’s or PhD is preferred.

• A minimum of 10–12 years of pertinent industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment is required.

• Experience in oncology is preferred.

• Proficiency in authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures is necessary.

• Experience in creating and managing briefing books is advantageous.

• Familiarity with regulatory submissions made to regulatory authorities is a plus.

• Strong knowledge of federal regulations, Good Clinical Practices, and ICH guidelines is beneficial.

• Project management capabilities related to medical writing are required.

• Ability to manage intricate writing projects with minimal oversight.

• Skill in editing text for conciseness and clarity.

• Ability to comprehend, interpret, and present complex clinical data effectively.

• Highly detail-oriented.

• Capability to coordinate multiple documents while efficiently managing timelines.

• A high degree of independence in decision-making and problem-solving.

• Understanding of FDA and ICH regulations and guidelines.

• Familiarity with eCTD-compliant templates and document formatting tools such as ISI Writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.

• Proficient in MS Word, with solid working knowledge of MS Excel, MS PowerPoint, and MS Project.

• Experience with an Electronic Document Management System (EDMS) such as Documentum, Core Dossier, or Veeva is preferred.

• Must possess proficiency in EndNote or RightFind Cite It.

• Ability to take ownership of decision-making for the functional area or program, resolve complex issues, and make trade-offs with minimal escalation.

• Ability to lead cross-functional collaboration and proactively drive stakeholder alignment.

🏝️ Benefits

• Comprehensive benefits package featuring various plans with a significant employer match.

• Opportunities for career advancement and development.

• Competitive compensation package.

• Annual target bonus.

• 401K with employer contributions.

• Generous stock options.

• Employee Stock Purchase Plan (ESPP).

• Starting with 20 days of Paid Time Off (PTO).

• 18 holidays, including Summer and Winter Break.

• Paid parental leave for maternity and paternity.

• In-office catered lunches.

• Home office setup provided.

• Lifestyle spending stipend.

• Commuter stipend for the Boston Office.

• Regular employee social events, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more.