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Senior Manager, Medical Writing Document Management

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

Your role at Genmab

Do you have advanced technical document specialist experience, and want to help drive the submission quality of the clinical documents authored by Genmab’s Medical Writing group?  If so, then you might be our next colleague to join Clinical Operations.

As a Senior Manager/ Associate Director, Medical Writing Document Management, you will drive the technical quality control aspects, ensure document submission readiness, and oversee the document quality reviews done by vendors, for all clinical documents authored by the Medical Writing group.

As an extended member of the Medical Writing Group, it is expected that you will help drive the optimization and implementation of processes to ensure compliant document compilation and adherence to the Regulatory Affairs Group’s submission publishing requirements. You will work in close collaboration with the medical writers to manage and track all MW deliverables and ensure documents are high-quality and submission-ready.  You will also support the medical writers with technical aspects of document management and other medical writing-related processes, as needed. 

The successful candidate will have high quality standards and a track record of meeting deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks simultaneously. Furthermore, you thrive working in an international environment, characterized by on-going changes of procedures, systems and processes.


Qualifications

  • 5+ years of relevant pharmaceutical/biotech/healthcare industry experience.

  • Experience performing electronic/technical quality control checks to ensure integrity of clinical study reports, clinical trial protocols/amendments, investigator’s brochures, clinical summaries, health authority briefing books, and health authority response documents.

  • Expert level skills in relevant computer software (eg, word processing, graphics, and document management systems), advanced document formatting functionalities, and bibliographic citation tools/software (EndNote) .

  • Experience creating and maintaining document templates in accordance with ICH guidelines.

  • Good understanding/knowledge of regulatory requirements and drug development processes, GCP/GXP, regulatory requirements, and guidelines associated with regulatory documents.

  • Experience compiling clinical study reports, appendices, and other complex documents and familiarity with publishing software.

  • Efficient at producing high-quality graphics for inclusion in protocols, CSRs, IBs, etc.

  • Experience adapting statistical output to make it suitable for intext presentation.

  • Adept with process development/optimization with an innovative mindset.

  • Effective planning and problem-solving capabilities and organizational skills.

  • Excellent written, verbal, and interpersonal communication skills.

  • Excellent stakeholder management skills.

  • Highly organized with the ability to manage multiple conflicting deadlines and competing priorities.

  • You can work independently, with a positive, can-do-attitude.

  • Demonstrate a structured and analytical approach.

  • Enthusiastic and comfortable cooperating and communicating across different functional roles.

Moreover, you meet the following personal requirements:

  • You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.

  • You are motivated and detail-oriented.

  • You have the ability to work across all trial phases and prioritize your own tasks.

  • You are a dedicated team player.

  • You are proactive and open-minded.

  • You have a quality mindset and thrive in a fast-paced and changing environment.

  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

 

Degrees of interest: 5+ years of relevant pharmaceutical/biotech/healthcare industry experience

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