Executive Medical Director

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Responsibility for Medical Affairs activities for Rare
Disease therapies with marketing authorization as
supporting access to our therapies in all relevant
management programmes.

RODUCT/BRAND REFERENCE POINT:
Continuously update own knowledge of products, therapeutic landscape, patient treatment/healthcare trends and access/regulatory developments within the Disease Area
Act as a 1st point of contact for the Country Medical Directors for clinical and non-clinical activities particularly for data dissemination
Act as 1st point of contact for medical &clinical queries for the Global, OPEL and Affiliate Market Access and Regulatory teams
Act as Medical Affairs Lead for relevant product OPEL Brand team(s)
Ensure delivery of OPEL led Medical Affairs Strategy and relevant tactics
Convey a clear message on legal and ethical standards to Kols , Investigators and HCPs
Develop an understanding and competence of SOPs, GCP and ICH, as well as legal and ethical standards
Immediately alert management or the Compliance Department to any possible compliance issues
Support the development of the OPEL Medical Rare Disease Team, which consists of Regional Medical directors, Scientific advisers and MSLs
Contribute to the development of the annual Regional Medical Plan, strategically aligned with and integrated with the Brand Plans, and ensure alignment with Global Strategy focusing on medicais affairs activities
Coordinate interactions among Regional Regulatory, Marketing, Outcomes Research, and Pharmacovigilance for all pan European medical activities including IISs
Partner closely with the OPEL and Regional Ethics &Compliance, Legal and Data Privacy teams as required
Integrate into the cross-functional Brand team(s) as the Medical Affairs lead for medical & clinical input
Work closely with OPEL Market Access to ensure all scientific/clinical/medical knowledge is integrated into e.g. GVDs, HTA dossiers, core claims documents etc.
Embed into Global Clinical and Medical Affairs teams to ensure that clinical trials or IST or any medical activities conducted in Europe are strategic in approach and compliant in execution
Partner closely with Global Regulatory teams to support strategic discussions on label requirements
Work closely with team-mates within the OPEL Medical Affairs team such as Medical Excellence, Medical Information, Patient Advocacy, RWE to ensure timely and efficient transfer of relevant knowledge
Work with the European Medical Team to identify top External Experts across the region and develop strong scientific and medically based interactions with them
Select and manage regional External Experts advisory board members, in collaboration with the Medical and Commercial directors or our partner as required
Assess promotional materials to ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner.
Contribute to the scientific content of promotional material, drawing on relevant scientific data and External Expert insights.
Ensure the regional commercial team receive initial andon-going medical training - in collaboration with the European Affiliate Medical Directors and/ or other Medical Manager(s) - enabling them to understand and convey the scientific benefits of a Brand appropriately.
Review training documents developed at regional level for commercial teams to check medical accuracy and compliance with regulatory requirements
Develop and deliver training to medical teams across the region on Otsuka products, medical concepts and available therapies
Translate scientific and clinical data into meaningful relevant medical information for health care professionals that ensure appropriate use of Otsuka products to secure optimal outcomes for patients
Support high quality medical activities such as Continuous Medical Educational Programs and Symposia
Develop and deliver presentations and prepare speakers for Otsuka symposia, in collaboration with relevant members of our partner, the Regional Medical /Brand Team
Develop Regional publications strategies and influential scientific publications
Develop and deliver materials for use by medical teams when communicating with HCPs and ensure that the medical teams are adequately trained on the materials
Identify and take informed business risks, escalating issues if needed.
Make and act on decisions while balancing speed, quality and risk.
Communication /development / medical affairs experience in the area of Rare diseases(essential)
Contributing to medical publications and presentations (essential)
Working across and building effective working relationships between Medical, Marketing and other relevant functions (essential)
Conducting complex negotiations within a pharmaceutical environment, both internally and externally (essential)
Budgeting, aligning local and regional plans (essential)

Advanced scientific and /or clinical degree - essential
Pharmaceutical Industry experience of at least 7 years in medical affairs & R&D - essential
Experience of drafting clinical trial protocols & leading clinical trials – essential
Experience of writing & publishing clinical / scientific manuscripts in peer-reviewed journals – essential
Knowledge of medical information, PV and QA requirements - essential
Detailed HTA support experience (writing and reviewing of GVD/HTA dossiers etc) in several EU countries – essential
Experience supporting Regulatory teams on the preparation and reviewing of SmPC according to EMA requirements - essential