Company: Advanced Clinical Recruitment Ltd
Reference: Global Medical Adviser
Closing Date: 14 Nov 16
Salary (£): Competitive
Based in Southall, UK. If you are interested in discussing this role further, please send an email with your CV attached to, email@example.com
The primary purpose of the role is to act as a global medical expert for the designated companies products; both marketed and in the pre-launch phase
The main responsibilities are as followed:
Providing global medical support for brand plan development and execution for designated products, (acting generally on behalf of the companies legal entities as required). See specific tasks below.
Planning, review and support for Phase IV studies including health economic and real world data programs.
Review of IIS proposals including liaison with business partners on study review.
Liaison with PV Physicians to ensure safety reporting requirements from company-supported IIS, Non Interventional and market research studies are met.
Provide cover for other medical staff, as required from time to time, subject to appropriate qualification, experience and training.
Reviewer/signatory for UK and European codes of practice.
• Provide medical support for global marketing; market access; publication activities, including support for brand planning; advisory boards; KOL engagement and support; congress & conference support; public relations activities; collaborative initiatives etc.
• Labelling support: Input to and review of regulatory applications and Variations; preparation of Medical Expert Statements and Clinical Overviews in conjunction with Medical Writing.
• Development and review of medical information, and marketing materials.
• Medical input to and delivery of training materials
• Copy approval, as final signatory.
• Global Brand Manager(s)
• Market Access staff
• Affiliate Medical Affairs teams
• Global Pharmacovigilance
• Clinical Development
• Central Medical Affairs / Medical Information
• Medical Writing
• Business Development where designated products involve partner companies
• External Partner Companies
• Regulatory Affairs
Key Committee Memberships:
• Medical Affairs Lead Team
• Brand Teams for products supported
• Labelling Committee
• Joint management committee with partner companies for products supported.
SKILLS & KNOWLEDGE
• Possesses the emotional intelligence and diplomacy to operate effectively at senior levels across the business
• Organized approach to work and able to prioritize work effectively.
• Ability to communicate accurately and effectively both verbally and in writing.
• Ability to work with multiple stakeholders in a matrix structure.
• Confident presentation skills.
• Effective member of teams, and also able to work well independently.
• Ability to rapidly assess information and reach conclusions or formulate further questions to ask.
• Strong interpersonal skills.
• Strong decision making and influencing skills.
• High quality written outputs such as letters, reports etc.
QUALIFICATIONS & EXPERIENCE
• Primary medical qualification and in possession of GMC UK registration or license to practice in an EU country.
• Some relevant experience, ideally in an Affiliate Medical Affairs role. Prior experience of collaboration with commercial staff, copy approval responsibility, management of product labelling & medical support in the preparation of regulatory submissions.
• Knowledge of regulations as applicable to the provision of medical information to healthcare professionals and members of the public.
• Working knowledge of applicable regulations, Codes of Practice, GVP, GCP, as applicable to the role.
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