Medical Writer

vor 2 Wochen

Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**THE POSITION**:
“Making science clear to improve patients’ lives.”

At Global Medical Writing, we provide end-to-end contributions to clinical development programs by writing key regulatory clinical documents. We currently have opportunities for (Senior) Medical Writers in our Therapeutic Area (TA) Medical Writing (MW) teams (CardioMetabolism & Respiratory; Inflammation; Oncology; CNS, retinopathies & emerging areas).

***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.- Furthermore you develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio. You share knowledge with other medical writers.- 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 Write r:
- 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 program.- You are responsible for the preparation of clinical documents required for phase transitions and regulatory approval of Boehringer Ingelheim (BI) development compounds (e.g. clinical trial reports, clinical summaries, investigator’s brochures, briefing books, clinical trial protocols), regulatory documents in the post-marketing setting, and value dossiers supporting health technology assessments.- Moreover you ensure quality and timeliness of clinical documents assigned to external providers by appropriate oversight, training, budget planning, and cost control.- You contribute to BI-internal international cross-functional working groups, and global SOP development.- You assume the role of an expert in the assigned TA, including thorough knowledge and understanding of the document and analysis standards.- You transfer knowledge when mentoring and training other medical writers.

***Requirements**:
- Doctoral degree in Pharmacy, Medicine or Life Science with multiple years of experience in scientific and/or regulatory medical writing or comparable degree with long term professional experience- 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- Excellent written and verbal English skills

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 HR Direct Team, Tel: +49 (0) 6132 77-3330.

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