CMC Writer, CMC Writing

Genmab; København; On-site; DKK 582,000 - 874,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab in Copenhagen, Denmark, is seeking a Regulatory CMC Writer to support global BLA/MAA/NDA filings, translating complex manufacturing and analytical data into clear regulatory narratives. You will join a dedicated CMC writing team and collaborate with scientists, project managers, and external partners to deliver high-quality submissions.

You will work with AI-enhanced tools, contribute to lifecycle maintenance, and ensure documents meet Genmab’s quality standards within tight timelines.

Qualifications

• Experience authoring and reviewing CMC regulatory sections with ownership of defined sections.
• Experience supporting global regulatory submissions (BLA/MAA/NDA) or pharma/biotech development.
• Understanding of CTD structure and CMC regulatory requirements across development stages.
• Knowledge of regulatory compliance, data integrity, and documentation standards (GxP).
• Excellent written English; ability to distill complex data into clear narratives.

Responsibilities

• Author and review Module 3 CTD sections: manufacturing, analytics, and formulation.
• Translate technical data into clear regulatory narratives with SMEs.
• Coordinate document prep with CMC PMs, QA, and external partners.
• Consolidate review comments and ensure timely approvals.
• Maintain trackers and support lifecycle maintenance of CMC docs.

Skills

CMC regulatory writing

GxP knowledge

Excellent written English

Attention to detail

AI writing tools

Stakeholder communication

Project coordination

Regulatory submissions

Education

Master's degree in science

Advanced degree or certification preferred

Job description

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.

The Role

Genmab’s CMC Writing team is looking for a Regulatory CMC Writer to support global marketing applications across our growing portfolio.

In this role, you will author and participate in the review of high-quality CMC documentation, with a primary focus on global Biologics License Applications (BLAs), Marketing Authorisation Applications (MAAs), and New Drug Applications (NDAs). Working closely with scientific and technical experts, you will translate complex manufacturing, analytical, and formulation development information into clear, accurate, and consistent regulatory submission documents.

You will join a dedicated team of CMC writers and collaborate with colleagues and external partners across late-stage development, regulatory submission, and lifecycle management activities. Your contribution will help ensure that CMC documentation presents a coherent scientific rationale and is delivered within agreed submission timelines. You will also contribute to improving writing quality and efficiency through the thoughtful use of AI and digital tools.

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

Key Responsibilities

Your primary focus will be CMC documentation supporting global BLA/MAA/NDA filings and responses to health authority questions during assessment.

Your Responsibilities Include

• Authoring and reviewing Module 3 CTD sections, covering manufacturing processes, process controls, analytical procedures, characterization, specifications, formulation development, stability, and facility
• Translating technical reports and source data into clear, scientifically sound regulatory narratives in close collaboration with subject matter experts
• Coordinating document preparation and review with CMC Project Managers, subject matter experts, Regulatory Affairs CMC, Quality Assurance, and external partners, including contract manufacturing organizations
• Consolidating review comments, facilitating their resolution, and ensuring that documents are completed and approved within agreed timelines
• Verifying the accuracy of data presented in CMC documents against source documentation and ensuring consistency across related sections and submissions
• Authoring and coordinating responses to health authority questions and implementing the resulting updates to CMC submission documents
• Maintaining source document trackers and ensuring traceability of supporting information and regulatory document updates
• Supporting lifecycle maintenance of CMC documentation, including post-approval changes, and contributing to IND/CTA submissions and amendments as needed
• Applying AI and digital tools to improve writing quality, consistency, and efficiency, while critically evaluating outputs and ensuring scientific accuracy and appropriate handling of confidential information
• Following and contributing to the continuous improvement of CMC writing and response principles, templates, internal procedures, and style guides
• Performing CMC writing activities in accordance with Genmab’s quality system and applicable procedures

Requirements

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

In Addition, You Have

• Experience authoring and reviewing CMC regulatory sections or supporting source documents, with the ability to take ownership of defined sections with limited supervision
• Experience participating in global regulatory submissions and/or a strong background in pharmaceutical or biotechnology product development and manufacturing processes. Direct experience supporting BLA, MAA, or NDA filings is a strong advantage
• A good understanding of CMC regulatory requirements across development stages and familiarity with CTD structure
• Knowledge of GxP, regulatory compliance, and documentation requirements relevant to CMC activities
• Excellent written English and the ability to distil complex scientific information into clear, concise, and well-structured text
• Strong attention to detail, with the ability to verify data, identify inconsistencies, and maintain scientific accuracy across documents
• Practical experience using AI tools to improve scientific or technical writing quality and efficiency, including the ability to formulate effective prompts, critically assess outputs, and verify scientific content
• Strong communication and stakeholder engagement skills, with the ability to coordinate cross-functional reviews and facilitate alignment without direct authority
• A proactive and structured approach to planning, prioritizing, and delivering quality work within demanding submission timelines
• A demonstrated track record of effective collaboration and reliable delivery in previous roles, together with curiosity, openness to feedback, and an interest in improving ways of working

Application deadline: 1. November 2026

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

DKK582.400,00---873.600,00

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.

Benefits

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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