Associate Director, Medical Writing

Genmab • Princeton, NJ

1d • Hybrid

About The Position

The Associate Director, Medical Writing is responsible for contributing to the medical writing portfolio within the clinical and regulatory areas. This includes authoring briefing documents, clinical trial medical synopses, protocols, investigator’s brochures, PIPs, CSRs, Health Authority briefing books, Health Authority responses, and other clinical documentation to support the conduct of trials and regulatory submissions/filings. The Associate Director participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. The Associate Director proactively leads departmental activities and various process improvement initiatives, and shares insights from lessons learned.

Requirements

• Strategic thinker with a big-picture orientation.
• Thorough, systematic, and organized.
• Proactive, accountable, and goal oriented.
• Innovative and a good team player.
• Excellent at sharing knowledge and acting as a mentor.
• Superior communication skills, capable of conveying scientific or medical information clearly and concisely.
• Exceptional planning and coordinating abilities.
• Ability to manage multiple tasks simultaneously.
• Extensive knowledge of English grammar.
• Expert in Microsoft 365.
• Analytical skills with the ability to interpret and present clinical data and other complex information.
• Advanced leadership skills to guide and mentor team members.
• Expertise in managing complex projects and submissions.
• Strong influence and representation skills in high-level cross-functional teams.
• Strategic vision to drive departmental goals and initiatives.
• High level of knowledge of regulatory requirements and compliance.
• Excellent oral and written communication skills to effectively present clinical results through scientific discussions, presentations, regulatory documents, and publications.
• Close interaction with internal and external stakeholders, including various functions within Development Operations, project teams, regulatory bodies, medical and safety personnel, investigators, professional associations, consultants, and clinical research organizations.

Nice To Haves

• Experience working in a fast-growing, dynamic company (or a strong desire to)

Responsibilities

• Independently author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions.
• Draft and edit more strategic documents, such as Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals).
• Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams.
• Lead submission team activities and oversee the preparation of critical documents.
• Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions.
• Act as a mentor for new employees and consultants and serve as a role model for junior writers.
• Lead the development and review of standard processes and templates.
• Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.
• Maintain up-to-date knowledge of relevant regulatory guidelines and requirements.
• Adhere to guidelines, SOPs, practices, and technical standards in all aspects of work.
• Maintain current knowledge and competencies within relevant therapeutic and professional areas.
• Contribute to knowledge sharing, skill-building, and good collaboration with stakeholders and colleagues.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed