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CMC Writer

CMC Writer

Genmab

Copenhagen, Denmark

The Role

The CMC area of Genmab is growing and looking for a CMC Writer to join the team in Copenhagen.

The CMC Writer supports with coordination and authoring of sections for regulatory CMC documents and replies to regulatory bodies.

The position reports to VP CMC.

Responsibilities

You will be responsible for coordination and support of:

  • Coordinate authoring and review of CMC sections of regulatory files e.g. INDs/CTAs, BLA/MAA, IBs;
  • Coordinate responses to HA and updates 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;
  • Support authoring and update of CMC Operations SOPs;
  • General GMP support in CMC Operations (deviations, change controls, CAPAs, risk assessments).
  • Requirements

  • Master's degree or equivalent and a solid background 3 - 5 years from working in a similar role within a biotech/pharma company;
  • In addition, you have experience in authoring and reviewing CMC sections of regulatory files;
  • It is expected that you have a proven track record of working in development and manufacturing of biologics;
  • Preferably with understanding of operational processes for all stages of development Ph I through Ph III.
  • Moreover, you meet the following professional requirements:

  • Proven experience working in teams;
  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines;
  • Ability to be proactive, enthusiastic 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.

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