Country Medical Director (UK) Endon United Kingdom,
As Country Medical Director UK you will provide coaching and leadership across the medical function and ensure high performance teams are established and colleagues developed. You will oversee the development and delivery of medical and scientific input to therapeutic brand teams to support all therapy area objectives and prepare the business to changes in the external environment.
Acting as a source of counsel on compliance-related matters and ensuring the affiliate is fully compliant with all relevant regulations and codes of practice, you will embed a Compliance Culture across all Regions of the business, ensuring a culture of ethics and compliance is strictly adopted.
Core duties will include:
- Develop a clear understanding and insight into the objectives across all brands and therapeutic areas to support and productively challenge the development of such objectives where clarify is required
- To ensure that the objectives for the brands and therapeutic areas are realised in compliance with the ABPI Code of Practice
- Oversee the processes for maintaining relevant product literature and developing /updating the relevant databases to ensure our medical information is accurate and of high quality
- Ensure that medical information enquiries are answered accurately and promptly in accordance with accepted standards (PIPA) in order to uphold the perception of Astellas in the market place
- Provide internal medical supervision and medical signatory of relevant marketing support material for the respective brands.
- To ensure all sign-off processes are efficient and timely and well communicated with the Medical, Marketing and Sales Departments.
- To ensure that competitor complaints are fully investigated and answered accurately and promptly to uphold the perception of Astellas in the market place.
- Oversee submission of new Marketing Authorisations (MA’s) as required by RAE including all regulatory activities required to support launch.
- To ensure Astellas UK is GxP inspection-ready and oversee any regulatory authority inspections
- Oversee the pharmacovigilance activities and ensure compliance with all relevant SOPs
- To provide support to the Clinical Operations Team to aid recruitment as appropriate
- Provide medical advice to the Company in relation to clinical research and studies
- Represent Astellas at external meetings
- Undertake self-study, company-provided training and scientific meeting attendance
- Maintain up-to-date knowledge of Regulatory guidelines, ABPI Code of Practice (UK) and Company SOPs to ensure adherence in all areas as appropriate.
- Pharma sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.
- Medical degree: full GMC registration and Licence to Practise
- Extensive/proven healthcare compliance expertise; to understand and comply with industry laws and regulations.
- Extensive pharmaceutical medical department expertise/experience
- Proven ability to utilise medical/ scientific knowledge
- Ability to proactively grasp complex sets of information and act/plan accordingly
- Good knowledge of at least one therapeutic area relevant to Astellas
- Medical writing experience
- Understanding and awareness of information sources
- Track-record of leading multi-year strategic planning process: strategic, organizational and problem-solving ability for sustained results.
- Proven leadership and people management experience including commitment to develop, coach and enable high performance standards.
- Proven ability to influence diverse senior stakeholders.
- Post graduate qualification such as MBA and/or MSc or equivalent is highly desirable.
- Fluency in written and spoken (Business) English (second EU language is an advantage)
- Computer literate
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