Regulatory Medical Advisor (m/f)
For our client’s team based at the Munich office, we are currently hiring an experienced
Regulatory Medical Advisor (m/f)
in a permanent employment contract full time.
Role & Responsibilities:
Clinical Development and Regulatory Strategy
- Provide regulatory advice on clinical development strategies for drug development from early development stages through to marketing authorization applications, line extensions and variations.
- Provide clinical advice on and author clinical regulatory documents like IB, IMPD, IND.
- Provide clinical advice and support clients in preparation of
- Scientific advice procedures with EMA and national competent authorities, including authoring and/or review of briefing document.
- Orphan designation procedures with EMA, including authoring and/or review of supportive documentation.
- Paediatric investigational plan procedures with EMA, including authoring and/or review of supportive documentation.
Marketing Authorisation Applications & License maintenance
- Provide clinical advice and support with preparation of the clinical parts of marketing authorisation applications under the centralised, decentralised or national scheme, including authoring and/or review of Clinical Overview (Module 2.5), Clinical Summaries (Module 2.7), responses to competent authority questions, Summary of Product Characteristics and post-marketing commitments.
- Provide clinical advice during the life cycle of a medicinal product and author the required clinical documentation for line extensions, variations and renewals.
The activities of a Medical Advisor include also but are not limited to
- Review and critique clinical documentation and provide hands on guidance for clinical document improvement
- Participate in client project teams as required
- Make presentations to clients or third party organisations
- Utilise, manage and mentor internal and external Medical Writers working on client programmes
- Provide therapeutic area advice/expertise/consultancy (internally and externally)
- Establish/develop and maintain client and opinion leader relationships
- Act as peer reviewer of clinical documentation prepared by other colleagues
- When required, participate in training of staff
- A university degree in human medicine (MD) is mandatory
- A minimum of 8 years of experience in clinical development or other relevant experience in the international pharmaceutical industry is required
- In depth knowledge and understanding of clinical development.
- A strong background in regulatory writing (IBs, clinical study protocols, clinical overviews) is strongly preferred
- Understanding of non-clinical and clinical R&D and product life cycle management
- Proficiency in English and ideally German language skills
- Strong communication skills and intercultural sensitivity
While applying for the job please refer to jobvector
About Constares GmbH
Constares ist eine branchenspezialisierte Personalberatung für die Life Science Branche, die von drei erfahrenen Beratern als mittelständisches inhabergeführtes Unternehmen gegründet wurde. Wir bieten sowohl die permanente Besetzung von Vakanzen als auch die Vermittlung von Experten auf dem Wege der Arbeitnehmerüberlassung oder auf freiberuflicher Basis. Für unsere...More about Constares GmbH