Hobson Prior are looking for an accomplished Senior Manager to join a growing biopharmaceutical company that specialises in the development and production of biosimilar products.
- Provide support to the VP Clinical Development with strategic planning and preparation of Clinical Development Plans and Target Product Profiles.
- Assure state of the art medical/scientific input into all relevant clinical and regulatory documents for all projects.
- Ensure clinical trial data is adequately reviewed, interpreted and presented for further discussions.
- Support the VP Clinical Development and/or Safety-Pharmacovigilance Officer in clinical safety and pharmacovigilance activities.
- Supervise and contribute input to the preparation and review of synopses, protocols, clinical trial reports, relevant sections of Investigational Medicinal Product Dossier, Investigator’s Brochure, safety reports, briefing documents, INDs, NDAs, etc.
- Assess data coding using MedDRA and WHO drug classification.
- Contribute to the clinical and pharmacovigilance databases reconciliation.
- Excellent verbal and written English skills.
- Strong capability of using a PC and Microsoft tools such as Word, Visio, Excel and Powerpoint.
- Strong organisation and management skills.
- Ability to lead, participate and make positive contributions.
- Experience in clinical drug development.
- Proven scientific background, including the development of biological drugs.
- Knowledge of GCP and GxP.
- Proven experience working on projects and managing people.
- Understanding of the International Conference of Harmonisation.
- Ability to travel when needed.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.