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Manufacturing and Controls (CMC) Writer

Posted: 11/6/2018
Location: Copenhagen, Hovedstaden
Category: CMC Operations
Req Number: Projects02153

Job Summary

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

The Chemistry, Manufacturing and Controls (CMC) Writer will provide support to the CMC Operations team, creating and coordinating the filing of regulatory documentation.

 

Key Accountabilities

  • Authoring and reviewing regulatory and technical documentation
  • Ensuring consistency across all documentation and participate in developing storyboards
  • Coordinating regulatory and technical submissions within CMC Operations.
  • Working closely with internal Genmab teams, such as CMC Operations, QA and RA 
  • Collaborating with external parties, including regulatory authorities and CMO partners.
  • Travelling up to 10 days per year as part of the work schedule.
  • Assisting in the maintenance and development of the CMC Operations Quality System.

Skills & Experience

  • Holder of a BSc or MSc qualification in Pharmaceutical Sciences, or related subject, preferably qualified to MSc level.
  • You have experience from the Pharmaceutical industry, with a background in drug development and manufacturing.
  • You have experience as a technical writer, authoring regulatory documentation including BLA’s, IND’s, MAAs, CTA’s and NDA’s.
  • You are experienced in the regulatory submission process and have a strong understanding of the required process, guidelines and regulations.
  • You have experience working closely with CMO’s and regulatory bodies.
  • You have excellent English language skills, both written and spoken.

About Us

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.  

If you would like additional information about this position before applying using the link, please contact Uthen Khamproh (ukh@genmab.com).

Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application. When uploading your application, it will be transferred to Korn Ferry for their processing. By clicking ‘apply now’ you will see how Korn Ferry manages your application and privacy.

To learn more about Genmab, you can visit our website: http://www.genmab.com/

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