Associate Director, Medical Writing

Genmab • Plainsboro Township, NJ

4d

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
We are looking for a highly motivated, independent and talented Associate Director of Medical Writing. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Associate Director of Medical Writing, you will be 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

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field preferred; advanced degree preferred.
• At least 8 years relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience preferred.
• Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting.
• Experience authoring clinical trial protocols (Phase 1-3) and clinical components in regulatory filings (NDA, BLA, MAA) is required. Additionally, experience preparing investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.
• Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize tabular and graphical data presentations.
• 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

Nice To Haves

• Oncology experience preferred.
• advanced degree preferred.

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.
• Lead the development and review of standard processes and templates.
• Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.
• Lead the development and review of standard processes and templates.
• Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.

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: Mid Level
• Number of Employees: 1,001-5,000 employees