Senior CMC Writer

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!

The Role

Genmab’s CMC Writing team is growing, and we are looking for a Senior CMC Writer to support global regulatory submissions across our expanding portfolio.

Your primary focus will be documentation for global Biologics License Applications (BLAs), Marketing Authorisation Applications (MAAs), New Drug Applications (NDAs), and responses to health authority questions during assessment. Working closely with scientific and technical experts, you will transform complex CMC information into clear, accurate, and consistent regulatory submission documents.

You will join a dedicated team of CMC writers collaborating across early and late-stage development, regulatory submission, and lifecycle management. As a senior colleague, you will independently drive writing activities, provide expert review and mentoring, and help improve documentation practices through AI and digital tools.

The position reports to the Director, Head of CMC Writing, and is based in Copenhagen, Denmark.

Key Responsibilities

Your responsibilities include:

• Independently authoring and coordinating review of Module 3 CTD sections and supporting source documents covering manufacturing processes and controls, analytical procedures, characterization, specifications, formulation development, stability, and facilities
• Working with CMC Project Managers, subject matter experts, Regulatory Affairs CMC, Quality Assurance, and external partners to resolve review comments and deliver approved documents within agreed timelines
• Serving as a go-to reviewer for scientific accuracy, document quality, consistency, and regulatory alignment, including verification of data against source documentation
• Authoring and coordinating responses to health authority questions and maintaining the resulting updates across submissions and programs
• Supporting late stage initial filings, global roll outs, lifecycle maintenance, including post-approval changes, and contributing to IND/CTA submissions and amendments as needed, while maintaining source document trackers and traceability
• Applying and refining CMC writing and response principles, templates, procedures, and style guides in accordance with Genmab’s quality system and applicable GxP requirements
• Using AI, automation, and digital tools to identify documentation gaps and improve writing quality and efficiency, with critical evaluation of outputs and appropriate handling of confidential information
• Mentoring colleagues in regulatory writing and digital documentation practices, and contributing to process improvements and departmental initiatives

Requirements

You hold a master’s degree in science or a related technical discipline. An advanced degree, relevant certification, or equivalent experience is preferred.

You bring at least six years of experience in CMC or a related field within the pharmaceutical, biotechnology, and/or medical device industry, with relevant experience in biologics and/or chemical development and manufacturing. We welcome candidates with backgrounds in biologics, small molecules, or both.

In addition, you have:

• Experience in global regulatory submissions and pharmaceutical or biotechnology product development and manufacturing. Direct experience supporting IND, CTA, BLA, MAA, or NDA filings is expected
• Demonstrated expertise in authoring and reviewing complex CMC regulatory sections and/or supporting source documents, with the ability to independently manage writing activities and guide other authors
• A good understanding of CMC regulatory expectations across development stages and strong knowledge of CTD structure, GxP, and relevant documentation requirements
• Excellent written English, sound scientific judgment, and the ability to present complex information clearly, assess supporting data, and identify gaps and inconsistencies
• Practical experience using AI to improve scientific or technical writing quality and efficiency, including effective prompting, critical assessment of outputs, and verification of scientific content
• Strong communication and influencing skills, enabling you to align cross-functional stakeholders, resolve differing perspectives, and mentor colleagues
• A proven record of ownership, effective prioritization, and timely delivery, combined with curiosity, continuous learning, and a collaborative approach that builds trust, welcomes feedback, and supports an inclusive work environment

Application deadline: 30 November 2026

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

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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