Medical Writer

Bavarian Nordic A/S

Ph.d. & forskning
Nordsjælland
Udlandet (øvrige)

Medical Writer

Principal to Expert Medical Writer

Job Responsibilities:

  • Work with clinical teams to understand the nature of the scientific work.
  • Conduct comprehensive literature searches to enhance background understanding of the topic, and evaluate the information and provide relevant insight to the clinical teams concerning the topic.
  • Compile, write, and edit medical writing deliverables covering all phases of clinical research for reporting and submission to regulatory agencies in accordance with regulations, standards, and guidelines.
  • Drive and manage the preparation of clinical documents such as clinical study reports, study protocols, risk/benefit analysis reports and investigator brochures.
  • Coordinate and conduct interdepartmental team review and document deliverables according to Bavarian Nordic guidelines and SOPs.
  • Prepare scientific documents including abstracts, manuscripts, scientific exhibits, posters and presentations.
  • Manage external vendors in medical writing, including vendor selection, task assignment, deadline negotiation, and oversight of medical writing deliverable quality.
  • Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
  • Stay current with current industry practices and regulatory requirements that affect medical writing. Keep abreast of current literature, emerging science, technological developments and medical trends.

Requirements:

  • MSc or PhD in life sciences or medical sciences, 5+ (prefer 8+) years of relevant medical writing experiences
  • Excellent written and oral communication skills in English language
  • Excellent scientific writing and editing skills with meticulous attention to detail, ability to communicate complex medical information in clear and compliant writing
  • Ability to understand and interpret complex data and scientific information; ability to assess data using his/her background knowledge and medical expertise
  • Familiarity with the principles of clinical research; has the ability to quickly develop expertise in new areas through comprehensive literature review as needed for the writing activities
  • Familiar with ICH, GLPs, and GCPs guidelines, and understand the levels of evidence required to achieve regulatory, marketing and regulatory goals
  • Profound understanding of pharmaceutical development, clinical research, regulatory requirements and medical terminology.
  • Strong organizational skills, curious and motivated
  • Able to work well independently or as part of a team in high-pressure situations
  • Flexible and proactive working style, attention to details and ability to meet deadlines
  • Knowledge in immunology, infectious diseases and oncology is preferred

#LI-HK1

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

Join Bavarian Nordic and take a step into the future of vaccines. Our goal is to develop innovative and safe therapies against cancer and infectious diseases to improve the health and quality of life for children and adults.

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Ph.d. & forskning
Nordsjælland
Udlandet (øvrige)
Humaniora
Kemi, Biotek & Materialer
Medicinal & Sundhed
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Bavarian Nordic A/S - hurtigt overblik


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Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
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