Medical Lead - Dublin
12 month contract initially.
35 Euro per hour.
The function of this role is to support the Head of Medical UK/IRE in the execution of Medical Affairs strategies in IRE. This will be achieved by the following aspects of the role:-Compliance with the IPHA Code (and other regulations)
- Keeping up to date with IPHA Codes/regulatory changes and processes.
- Apply compliance expertise to the medical activities to ensure business needs are meet.
- To help ensure that all relevant materials has been vetted through promo mats before use.
- Assist in the development of new claims for key brands.
- To provide medical review / approval/certification of promotional materials for scientific meetings, symposia and other medical education activities.
- To be accountable for the medical strategy and tactics of new product launches.
- Assist in the defence of key claims and activities upon challenge by competitor companies.
- Challenge competitor advertising as appropriate and assist in the preparation claims against competitors.
- Approve and supervise non-interventional studies
High quality medical / scientific support:-Externally
- Provide medical expertise, advice, and information across the companies portfolio.
- To be the accountable medical advisor and expert for the relevant franchise
- Keep up to date with relevant medical/scientific developments.
- Develop individual professional relationships with top local External Experts through non-promotional scientific dialogue pertinent interests.
- Help coordinate and assist in the medical teams with external expert relationships.
- Lead/participate in medical and scientific forums (e.g. Advisory Boards) that involve (as relevant) local/regional/national KEEs.
- Actively work on pipeline strategies and engage with external stakeholders.
- Develop relationships with key local/regional/national professional societies and organisations.
Education and Experience required:
- Registered and Licensed Heath care professional desired but extensive medical affairs experience is preferred
- Extensive experience of working in Ireland and knowledge of IRE pharmaceutical environment
- With or working towards a higher Medical/Scientific Qualification
- Extensive experience working as a final signatory or code Knowledge - at least 2 years
- Minimum clinical experience of having completed Core Medical Training is desired
- Specialist accreditation and/or Specialist Training is desired
- 2 ½ years plus Pharmaceutical Industry experience covering the leadership of a broad set of medical activities including clinical trials, medical affairs, compliance/ final signatory and external engagement
- Experience of setting, balancing and managing a budget to target is required
- Line management experience is desired ? Ability to lead, manage and develop teams.
- Detailed knowledge of Regulatory guidelines and IPHA Code of Practice and standard operating procedures, and experience of their implementation within the business environment including final signatory status
- Principles and practice of medical affairs including clinical trial design, management, analysis and reporting, including GCP
- Preferred knowledge of specific products and related therapeutic areas, including key opinion leaders
- Knowledge of the structure and management of the HSE