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CMC Writer

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 
 

The Role

The CMC area of Genmab is growing and the Stability and Submission Support team is looking for an experienced CMC Writer to join us in Copenhagen.

The CMC Writer specialist role is responsible for the authoring and coordinating activities needed to complete the Module 3 documents for IND/CTAs, amendments, HA response rounds, and BLA/MAAs. This CMC Writer role requires solid experience as a CMC writer, preferably with several IND/CTAs and a BLA/MAA. Previous experience with Module 3 for manufacture of engineered antibodies is an advantage.

As a CMC Writer, you will be working as part of CMC Management Team, where you will be responsible for ensuring timely completion of Module 3 documents. You will be collaborating with CMC Project Managers, CMC Subject Matter Experts, Regulatory Affairs and Quality Assurance. As Genmab has an outsourcing business model, previous experience with collaborating with CMOs is an advantage. 


Responsibilities 

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

  • Author and coordinate completion of Module 3 sections of regulatory files e.g. INDs/CTAs, CMC amendments, and BLA/MAA

  • Coordinate and author responses during Q&A response rounds

  • Collaborate and align 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

  • Participate in continuous improvements and optimizations for the CMC Writing

  • General GMP support in CMC Operations (deviations, change controls, CAPAs, risk assessments)


Requirements

  • Master's degree or equivalent and a solid background of 3-5 years from a biotech/pharma company

  • Experience with authoring and reviewing CMC sections of regulatory files

  • Proven track record of working in development and manufacturing of biologic preferably with understanding of operational processes for all stages of development Phase I through Phase III

  • You have a flair for language and understand the importance of choosing suitable wording in regulatory documentation

 

Moreover, you meet the following professional requirements:

  • Experience with working in CMC Management Teams

  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines

  • Ability to be proactive, and goal orientated

  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

  • Strong communication skills - both oral and written

 

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

Degrees of interest: Healtcare - Pharmacy, Medicine - Medical Biotechnology

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