Medical Manager

• Location: Reading

About the job

The Medical Manager is responsible for, contributing to and delivering evidence generation aspects of local medical plans across the UK and Ireland for Specialty Care.

Main responsibilities:

• Acting as Subject Matter Expert (SME) for conduct of all scientific/clinical research within Speciality Care Medical Department in compliance with company SOPs.
• Responsibility for project management of externally sponsored studies (ESR) to meet the local business, regulatory, safety and ethical requirements.
• Responsibility for project management of company-sponsored studies (CSS) to meet the local business, regulatory, safety and ethical requirements.
• Providing strategic input to all relevant processes.
• Supporting the Head of Medical Operations, Compliance and Governance across the Specialty Care Business Unit, including support for Risk Minimisation Materials oversight and Managed Access Programmes management as required.

KEY RESULTS/ACCOUNTABILITIES

1. Excellence in ISS execution by acting as SME for all aspects of ISS management.

• Ensure all proposals are reviewed and approved locally (LSRC).
• Draft all contracts and lead negotiation to execution (in conjunction with Legal advice.
• Undertake due diligence and fair market value processes for all studies and respond to queries from the Global Benchmarking team.
• Manage processes relating to investigational medicinal product, including forecasting, receipt of drug and resolution of all issues.
• Ensure regular status updates with Medical personnel in each Franchise.
• Ensure all publications are compliantly reviewed.
• Train Medical staff in the ESR process, including use of the ESR portal.
• Provide input to local process changes.
• Ensure all information and documentation is archived appropriately.

2. Excellence in CSS execution by acting as SME to improve quality, timelines and delivery

• Identify and engage key stakeholders ensure timely and successful set up of a local study (e.g. Global, Clinical Study Unit, PV, Regulatory, Procurement, Legal).
• Assist with procurement of suitable vendors to conduct studies and help provide solutions to study-related issues using best practice.
• Advise franchises on internal and external processes (including e.g. ethics and health authority approvals).
• Improve study metrics by helping franchise teams navigate local and global SOPs e.g. identify correct templates to use to write protocols, clinical study reports etc.
• Assist franchise teams on all study-related issues.
• Develop / provide input to local process changes.
• Assist franchise teams to ensure all information and documentation is archived appropriately.

3. Other activities within Medical

• Responsible for preparation and submission of annual Transfer of Value reporting for all evidence generation activities.
• Assist in audit and inspections as required and provide strategic responses where appropriate.
• Assist in oversight of RMMs for all Specialty Care products.
• Undertaking any other tasks, including Managed Access as required for the Medical Manager function.

4. Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (including the Industry Code of Practice, Sanofi Policies and Procedures and any relevant legal requirements); and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.

6. Environmental and Safety Leadership

• To care for his/her own safety and wellbeing and the safety of others, and to cooperate with the company to ensure a safe place of work. Employees are therefore expected to:
  • Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
  • Report any accident, incident or near miss, whether it be of personal injury or property damage.
  • Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence.
  • Thoroughly read all safety documentation issued by the Company and comply with its requirements. Escalate any doubts or uncertainties to their supervisor and/or manager.

About you

• Educated to degree level or higher level scientific qualification or equivalent.
• Proven project management capability.
• Strong organisation skills, ability to prioritise own workload and deal with changing priorities.
• Experience/knowledge of clinical trial design, management, analysis and reporting, including GCP principles.
• Knowledge of Regulatory guidelines, Medicines Act and the Human Medicines Regulations, ABPI/IPHA Code of Practice and Standard Operating Procedures, and experience of their implementation within the business environment.
• Thorough knowledge of relevant GxP, company procedures, therapy areas and products.
• Preferred knowledge of Specialty Care products and related therapeutic areas.
• Knowledge of the structure of the NHS.
• Communication skills, written, verbal & non-verbal ability to communicate at all levels.
• A team player with a flexible approach, able to collaborate and build cross-functional relationships.
• Ability to learn quickly in a fast-paced environment.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.
• If you have a disability and require adjustments for the interview process, please email us at diversity.recruitmentUKIE@sanofi.com. We are dedicated to ensuring an inclusive and supportive experience for all applicants.

Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.

We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.

If you have a disability and require adjustments for the interview process, please email us at diversity.recruitmentUKIE@sanofi.com. We are dedicated to ensuring an inclusive and supportive experience for all applicants.

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