Boehringer Ingelheim Pharma GmbH & Co.KG - Senior Medical Writer
(Senior) Medical Writer - 210789
Tasks & responsibilities In your new role as Medical Writer:
- You are responsible for the preparation of clinical documents required for advancing clinical development programs (e.g. clinical trial reports, investigator’s brochures, clinical trial protocols). This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines.
- You ensure quality of clinical documents assigned to external providers by appropriate oversight and training.
- You develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio.
- You advance MW standards by contributing to process improvement initiatives and working groups with cross-functional impact
In your new role as a Senior Medical Writer:
- You assume the role of project medical writer across all phases of clinical development. You proactively coordinate with other functions, plan timelines, and devise and execute document strategy in a clinical development programs. You write clinical submission documents.
- You assume the role of an expert in the assigned TA. You transfer knowledge when mentoring and training other medical writers
- Doctoral degree in Pharmacy, Medicine or Life Science with multiple years of experience in scientific and/or regulatory medical writing
- Excellent written and verbal English skills
- Sound knowledge of medical concepts, statistics, pharmacokinetics, and pharmacodynamics
- Ability to independently and effectively communicate complex clinical information in writing
- Ability to manage projects effectively across regions and in matrix environments
Additional requirements for the Senior position:
- Longstanding experience in regulatory medical writing (as a Medical Writer or an equivalent role)
- Proven ability to work globally on clinical documents for submission to health authorities in major regions such as US, EU and Asia
- EMWA/AMWA foundation or advanced certificate is an asset
Ready to contact us?
Please contact our Recruiting EMEA Team: Julia Zeller, Tel: +49 (7351) 54-7232
We look forward to receiving your online application!
Grow with us: www.boehringer-ingelheim.de/karriere