Director, Medical Writing

At Genmab we are dedicated to building extranotordinary 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!

Role:

The Director Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical documentation to support the conduct of trials and regulatory submissions/filings.

The Director Medical Writing 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. This role collaborates with the other members of the Medical Writing Leadership Team to manage the planning oversight and execution of the Medical Writing portfolio drive strategic initiatives and identify development areas within Medical Writing.

Responsibilities:

Document Creation and Review:

• Lead the planning and authoring of complex strategic clinical and regulatory documents including clinical trial protocols amendments clinical study reports and investigators brochures.

• Oversee the preparation of clinical overviews summaries in CTD/eCTD format for regulatory submissions Health Authority briefing books responses and scientific publications (abstracts posters slide presentations and manuscripts).

Team Leadership and Collaboration:

• Represent medical writing on internal teams such as the Clinical Development Team and/or Clinical Trial Team protocol review committee regulatory submission teams and ad-hoc working groups to support company initiatives.

• Independently lead cross-departmental submission teams ensuring high performance standards and compliance with regulatory requirements.

• Mentor new employees and consultants and serve as a role model for junior writers.

• Guide medical writing staff during the planning and execution stages across all document types and regulatory submissions.

Process Development:

• Lead the development review implementation and improvement of departmental processes policies standard operating procedures training and work guidance.

• Initiate and drive strategic Medical Writing initiatives and processes to ensure alignment with company priorities.

• Manage the oversight of Medical Writing vendors/CROs ensuring high performance standards are met.

Regulatory and Quality Adherence:

• Maintain up-to-date knowledge of relevant regulatory guidelines and requirements.

• Ensure adherence to guidelines SOPs practices and technical standards in all aspects of work.

Professional Development:

• Maintain current knowledge and competencies within relevant therapeutic and professional areas.

• Contribute to knowledge sharing skill-building and good collaboration with stakeholders and colleagues.

Requirements:

• Bachelors degree in science or related area; Masters/advanced degree preferred

• 12 years in clinical or regulatory medical writing in biotech/ pharma industryor 15 years of relevant cumulative biotech/pharma industry experience with at least 10 years regulatory Medical Writing experience

• Oncology experience required

• Significant experience in writing/leading the writing of critical clinical documents in major regulatory filings (NDA BLA MAA)

• Advanced familiarity with all phases of drug development and a clinical operations organization

• Significant experience in working with drug development processes Good Clinical Practice (GCP) regulatory requirements and guidelines associated with all regulatory documents (including CTA/IND submissions protocols investigator brochures and clinical study reports)

• Significant experience managing/guiding internal cross-functional teams

• Experience in managing a functional team/overseeing the work of other writers/CROs/vendors

• Proven performance in earlier role/comparable role

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

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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.