Job Purpose
As a member of the UK & Ireland Rare Diseases Leadership team, this role is pivotal to the continued success of Recordati's UK and Ireland rare diseases business. The role will lead the rare diseases medical department in the UK & Ireland providing support for the business in launching new products and managing the current portfolio, balancing the drive for commercial success with high ethical standards and appropriate regulatory compliance.
To develop key customer relationships to understand the patient journey (epidemiology, diagnostics, accessibility to the treatment, to increase disease awareness and to facilitate scientific programme development).
Provide strategic medical vision with acute business acumen and the ability to identify and develop future opportunities for the UK & Ireland Rare Diseases business and oversight of the regulatory and QA processes in the UK & Ireland. Recordati supports flexible working - this role will be based from our Hemel Hempstead office a minimum of 3 days per week.
Key Responsibilities
Establish and Lead the Rare Diseases country medical function:
- Position the product portfolio within relevant national and regional protocols to enable the commercial teams to maximise patient opportunities.
- Liaise with the Market Access team to facilitate national and local reimbursement for the relevant portfolio.
- Ensure ABPI compliance code training is undertaken for the relevant UK & Ireland team.
Establish and develop a rare diseases KOL, stakeholder group and market understanding:
- Develop a KOL/Advisor network to leverage opportunities for the product portfolio.
- Ensure regular contact as required with UK & Ireland KOLs in relevant disease areas by the Medical Affairs / MSL team.
Development and implementation of a Country Medical Plan:
- In collaboration with the UK Rare Diseases Management Team develop brand plans, incorporating medical activities such as advisory boards, local study programmes, national projects and KOL development programmes.
Development of training materials & promotional materials:
- Ensure that all training materials remain compliant and approved in line with local regulations.
Required Education
- A medical qualification is required.
Required Skills and Experience
- Minimum 5 years of experience in a complex medical affairs role.
- ABPI final medical signatory is essential.
- Line manager experience - the role will be responsible for the management and development of a small team.
- Regulatory Knowledge: Thorough understanding of regulatory requirements and submission processes for pharmaceuticals and medical devices.
- Pharmacovigilance: Skilled in monitoring, assessing, and reporting drug safety and adverse events, maintaining compliance with pharmacovigilance standards.
- Medical Affairs: Ability to provide scientific and clinical guidance for product launches, lifecycle management, and communication with healthcare professionals.
- Data Interpretation: Strong capabilities in analysing medical data, interpreting research findings, and drawing meaningful conclusions for business and clinical decisions.
- Medical Writing: Experience in authoring clinical study reports, regulatory documentation, scientific publications, and educational materials.
- Scientific Communication: Effective presentation of complex medical information to diverse audiences, including regulatory agencies, and internal stakeholders.
- Therapeutic Area Knowledge: Expertise in oncology, staying current with advances in disease management and treatment options.
Required Behaviours and Competencies
- Leadership and Strategic Vision: Ability to set medical strategy, inspire teams, and drive organisational goals through clear vision and direction.
- Scientific Expertise: In-depth knowledge of medical science, clinical development, and regulatory requirements relevant to pharmaceutical products.
- Ethical Integrity: Commitment to ethical standards, patient safety, and compliance with industry regulations.
- Communication Skills: Strong written and verbal communication skills for engaging internal stakeholders, healthcare professionals, and regulatory bodies.
- Collaboration and Influencing: Proven ability to work cross-functionally, build consensus, and influence decision-making at all levels.
- Problem-Solving and Decision-Making: Analytical thinking and sound judgement to address complex medical and business challenges.
- Continuous Learning: Commitment to ongoing professional development and staying abreast of scientific advances and changes in regulatory landscapes.
- Patient-Centricity: Focus on improving patient outcomes and ensuring the safe and effective use of medicines.
- Adaptability: Ability to respond positively to change and manage uncertainty in a dynamic industry environment.
- Project Management: Skills in planning, executing, and overseeing medical projects.
Required Languages
Written and spoken English.
Travel required
20%
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
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