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.

#LI-remote

 

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.

At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. 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. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

 

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.

Please note that all applicitions must b send through our webpage: 
https://genmab.wd3.myworkdayjobs.com/en-US/Genmab_Careers_Site/details/…

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

 

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

Job details
Work experience:
Work experience is required
Duration of work experience:
Between 2 and 5 years
Language skills:
  • English
  • Good
Number of positions:
1
Date of expiry:
Link for more information:
About company

ATTENTION: IF YOU WOULD LIKE TO APPLY TO ANY OF OUR AVAILABLE POSITIONS, PLEASE DO SO THROUGH THE LINK IN EACH VACANCY "LINK FOR MORE INFORMATION" "APPLY HERE"! WHO WE ARE Delivering on our promise for patients Founded in 1999 in Copenhagen, Denmark, we are a dual-listed, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. We are led by an experienced international management team. Our proprietary product pipeline and next-generation antibody technologies are the result of our strong company culture and a deep passion for innovation. We are inspired by nature and the power… Read more