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Senior Technical Writer
@DK001 Genmab A/S
[Hiring] Senior Technical Writer @DK001 Genmab A/S
Mar 29, 2025 - DK001 Genmab A/S is hiring a remote Senior Technical Writer. 💸 Salary: unspecified. 📍Location: Northern America, Europe, Asia.
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Role Description
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).
- 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.
- Collaborate 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 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.
Qualifications
- Master's degree or equivalent.
- 5-8 years of experience in product development and manufacturing processes in the pharma/biotech industry.
- Experience in authoring and reviewing CMC sections of regulatory files and participating in global regulatory submissions.
- Proven track record of working in development and manufacturing of biologics.
- Understanding of operational processes for all stages of development (Phase I through Phase III).
- Prior knowledge of antibody-drug conjugates or chemical linkers is an advantage.
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-oriented.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
Benefits
- Maximized efficiency of an agile working environment for better employee work-life balance.
- Open, community-based office spaces that connect employees while being immersed in powerful laboratories.
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| 📍 | Be aware of the location restriction for this remote position: Northern America, Europe, Asia |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
Writing
Writing
|
Salary
💸
unspecified
|
Remote
Location
Northern America, Europe, Asia
|
|
Job Type
full-time
|
Posted
Mar 29, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: Northern America, Europe, Asia |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
