Senior Technical 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

The Genmab CMC Writing Team is looking for a Senior Technical Writer for our growing project portfolio.

As a Senior Technical Writer at Genmab, you will be part of a highly dedicated and specialized cross functional team leading the late-stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA).

In this role you will work with authoring and coordinating review of CMC sections of regulatory files e.g. INDs/CTAs, CMC amendments, and BLA/MAA, covering process, analytical, and formulation development activities.

This position reports to Director CMC Writer based in Copenhagen and is a hybrid role

Responsibilities
The responsibilities of the role will include, but is not limited to;

• Author and coordinate review of CMC sections of regulatory files e.g. INDs/CTAs, CMC amendments, and BLA/MAA, covering process, analytical, and formulation development activities.
• Coordinate and author responses to HA questions and consequential updates to CMC sections of regulatory files. The coordination is done in collaboration with internal and external stakeholders like CMC Project Managers and Subject Matter Experts, Regulatory Affairs and Quality Assurance and external CMOs.
• Participate in lifecycle maintenance of regulatory documents. Maintain source document trackers.
• Collaborate with PMs and other reviewers/ approvers to address the comments and ensure resolution within agreed timelines.
  Work in accordance with CMC writing principles including use of templates, SOPs and style guides for Genmab projects.
  Ensure that CMC activities are performed in compliance with Genmab's quality system

Requirements

• Master's degree or equivalent, and a solid background of 5-8 years from working with product development and manufacturing process in pharma/ biotech industry.
• In addition, you have experience in authoring and reviewing CMC sections of regulatory files and participating in global regulatory submissions.
• It is expected that you have a proven track record of working in development and manufacturing of biologics, preferably with an understanding of operational processes for all stages of development (Phase I through Phase III).
• Prior knowledge of antibody-drug conjugates or chemical linkers will be an advantage.

Moreover, you meet the following professional requirements:

• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders
• Strong communication skills - both oral and written
• Ability to be proactive, and goal orientated
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines

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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Location: Copenhagen - Carl Jacobsens Vej 30