Associate Director, Medical Writing

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.

 Your key responsibilities will be:

Key Accountabilities

• 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.

Skills and experience

• 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.

Moreover, you meet the following personal 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

For US based candidates, the proposed salary band for this position is as follows:

$160,080.00---$240,120.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. 

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 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 

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

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

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.