An internationally renowned pharmaceutical organisation is seeking to hire a Medical Manager to their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
- Developing the Medical Plan/Strategy for the company in the UK.
- Collaborating with internal stakeholders to ensure the timely delivery of information on brand strategy, new clinical data, new regulatory and safety information, and accurate, balanced, and up to date materials to use in medical to medical communications.
- Ensuring the compliance of all medical activities with ABPI Code of Practice, PAGB, and relevant SOPs, regulations, and guidelines.
- Working with key external stakeholders, supporting goals, and bringing external insights to the organisation to shape strategy and providing focused, relevant information in response to their needs.
- Ensuring that product materials and related activities reflect the most up to date regulatory labelling, risk management plans, and regulatory commitments whilst meeting ABPI code/PAGB/inter-company requirements.
- Providing medical input within regulatory submissions, clinical overviews, license variations, and CDS updates as required.
- Providing input into HEOR submissions, HTA dossiers, clinical guideline consultations, and regional formularies as required.
- Supporting issues related to supply and distribution, product quality, benefit-risk, market actions, and product withdrawals.
- Supporting investigator-initiated research (IIR) studies to ensure that appropriate records are kept, and that progress is monitored.
- Supporting media, government, and patient group activities, including policy development, corporate initiatives, and issues management.
- Participating in local, regional, and global cross-functional project teams related to the product brand.
- Working closely with Commercial teams to assess business development opportunities in the Urology therapeutic area.
Skills and Requirements:
- Medical, pharmacy, or postgraduate level science degree.
- Desired experience of 3-5 years in medical affairs within UK OTC environment, deep PAGB, and ABPI compliance processes knowledge.
- Proven ability to interact with KOLs and Government Officials.
- Demonstrated ability to create and articulate medical brand strategies.
- Proven ability to lead and manage in a complex environment (e.g. across markets, functions).
- Knowledge of the therapeutic area is a strong advantage.
- Knowledge of commercial and environmental aspects of the pharma business.
- Experienced in project management.
- Demonstrated ability in design, initiation, and reporting of clinical studies as part of an integrated clinical plan.
- Able to discuss scientific aspects of regulatory issues and discuss commercial issues.
- Able to review, evaluate, interpret, and present complex data.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
An internationally leading pharmaceutical company is seeking to recruit a Global Medical Lead Rare Immunology to their office in Switzerland.
An oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer is advertising a vacancy for a Medical Affairs Expanded Access Manager.