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

 

We are looking for a highly motivated, independent and talented Medical Writing Manager. Senior Manager and Associate Director level available for more experienced candidates. As a member of the medical writing team, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As a Medical Writing Manager, you will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistency across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

 

The successful candidate will have strong analytical skills, high quality standards and is committed to meet deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks simultaneously.

 

We offer a position where you will be involved in strategic project, as well as trial-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. You will also be involved in developing processes and tools to support further development of the department.

 

Your key responsibilities will be:

Key Accountabilities

  • Draft and edit documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator’s brochures, and clinical study reports, including subject narratives. Additionally, may be responsible for drafting or assisting in drafting edit Health Authority briefing packages, Health Authority responses, and clinical CTD submission documents.
  • Drive trial team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions.
  • Provide peer review and editing support for other clinical/regulatory documents, as needed.
  • Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work.
  • Support developing and reviewing standard processes and templates.
  • Work effectively in cross-functional working groups. 

 

Skills and experience

  • At least 5 years’ medical or scientific writing or editing experience, preferably in the pharmaceutical industry.  Oncology experience highly preferred for senior-level consideration.
  • Experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred.
  • Basic familiarity of the drug development process, clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
  • Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
  • Knowledge of or experience writing protocols, investigator’s brochures, and clinical study reports. Senior level candidates should also have knowledge of Health Authority briefing packages, Health Authority responses, and Paediatric Investigational Plans (PIPs). 
  • General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
  • Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems.
  • Ability to interpret and summarize tabular and graphical data presentations.

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 and a great communicator with excellent oral and written communication skills.
  • 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.

Other            

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 specialized 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.  

#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 applications must be send through our homepage:
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.

 

Scam alert

Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation.  This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.

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