Senior Manager Medical Writing

Your activities

  • Drafting and reviewing clinical, medical, regulatory and pharmacovigilance documents (e.g. IDSMB reports, DSURs, RMPs, study protocols, ICFs, CSRs, IBs, paediatric investigation plans, briefing books)
  • Ensuring the quality check of documents before the release of each version
  • Development and maintenance of processes, guidelines, and templates
  • Technical management of a group of medical editors
  • Contact person for issues within the group
  • Organisational development

Your background

  • Completed scientific studies​
  • Very solid experience in the field of medical writing (oncology indication would be a plus)
  • Strong knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.)
  • Solid experience with global marketing authorisation applications for medicinal products, ideally with MAA/NDA
  • First management experience is desirable
  • Excellence written and spoken English skills

Your benefits

  • Challenging projects in interdisciplinary and highly professional teams
  • Flexible working hours with an attractive salary/benefit package
  • Possibility to perform 100% homeoffice
Gender note

For reasons of better readability the language forms masculine, feminine and diverse (m/f/*) are used simultaneously. All references to persons apply equally to all genders.

Type of contract

Permanent Position

Industry

Pharmaceuticals

Department

Medical Affairs

Location

Remote

Germany

Entry date

ASAP

Duration

Permanent

Remote

ja

Capacity (FTE)

1

Your contact person
hexagon_portrait_6
Karoline Gutensohn

Senior Recruiting Managerin

Interested?

We are looking forward to your application!

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