Competitve Salary and Benefits
Medical and Clinical Affairs Scientist - Wiltshire
Our Client is a global technology enterprise, providing new inventions that defy convention and simply work better. Based on their growth in new technologies including medical devices, they are seeking a senior level Medical and Clinical Affairs Scientist to ensure that our Clients' 'Compliance & Approvals' (C&A) team ensures that all their current and future products meet the legal requirements for all countries of sale, gaining the necessary approvals or registrations in the appropriate time frame.
- The Medical and Clinical Affairs Scientist will be 'hands on' and fully involved in all aspects of medical Affairs and Clinical Research for medical devices.
- The Medical and Clinical Affairs Scientist will be responsible for the entire lifecycle of the product/ project including clinical projects, from concept and design of products through to claims, copy approval, expert engagement, clinical trials, ethics/ regulatory submissions, implementation, reporting, publications, post marketing activities including medical information and update of regulatory documents.
- The role includes the creation of medical affairs and clinical SOPs, regulatory documents, developing and reviewing clinical documents.
- Cross-functional working with internal functions/departments globally, including but not limited to: Engineering, Research, Commercial, Claims, Legal, Regulatory, Quality, Sensory, Packaging & Labelling and Manufacturing.
- The role benefits from growth opportunities within the Global and Regional Medical Affairs and Clinical Affairs functions, as the teams within both the functions are being developed from the ground up.
- Implement the Global medical/non-promotional strategy/plan for the respective product.
- Manage the safety evaluation and risk management for the respective product through its lifecycle including post marketing.
- Provide expert support relating to products, treatment trends, and scientific activities within therapeutic area for internal stakeholders and external professionals.
- Access promotional and non-promotional materials to ensure that all claims are supported by scientific data and presented in an accurate, fair, and balanced manner, ensuring compliance with relevant codes and SOPs.
- Develop and maintain direct contact with external experts to gather insights and input on treatments.
- Identification and liaison with relevant key opinion leaders (KOLs). Develop strong peer to peer scientific partnerships.
- Overall responsibility for setting the clinical strategy including clinical operations, with a focus on clinical investigations and evaluations for regulatory purposes and marketing trials.
- Responsible for interfacing with ethics committees and obtaining applicable ethics approval for proposed studies.
- Ensuring compliance with all relevant regulatory requirements in cooperation with Quality and Regulatory Affairs, the legal department and any relevant protocols set by the company.
- Provide adequate, maintained devices for clinical activities to meet the strategic goals of the Company.
- Work with Quality, Regulatory and Compliance departments to prepare documentation for submissions to obtain regulatory approval for commercialization of medical devices, supporting regulatory inspections/audits.
- Develop and implement clinical marketing plans for the respective project, serving as a relationship manager and spokesperson in clinical marketing and outreach activities.
- Reviewing, obtaining and providing medical, clinical and scientific input on content of device labelling and promotional material.
- Select and manage vendors to assist in necessary operational aspects of running clinicals as budget and resources permit.
- Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical investigation and evaluation reports, publications and internal/external presentations. Including post-market follow up studies.
Qualifications and Requirements
- More than 3 years' experience in the pharmaceutical, medical device or cosmetic sector.
- Science Degree or other relevant degree or qualification (PhD an advantage).
- Proven medical affairs/clinical research management/leadership experience (preferably within a medical device company).
- Knowledge and understanding of the regulatory process and associated governance of medical devices. A working knowledge of Medical Device and IVD Directives.
- Experience of US FDA regulations advantageous.? Working knowledge of relevant international standards and guidelines.
- Occasional travel to conduct site visits, KOL engagement and research conferences would be required globally.
Experienced in the use of the following:
- PAGB code.
- Quality Management Systems ISO 13485.
- ISO 14155: 2011* Clinical investigation of medical devices for human subjects - Good Clinical Practice.
- ISO 14791: 2012 * Risk Management.
- IEC 62366:2015 Application of?usability engineering?to?medical devices.
- ICH GCP guidelines.
- Proven experience of managing clinical investigations and evaluations from planning, obtaining ethics committee approvals, implementation and successful completion.
- Medical writing and statistical analysis skills advantageous.
- Safety and Risk Management experience desirable.
- Knowledge of consumer products beneficial.
- Hands-on, collaborative, innovative, demonstrating leadership, ownership and accountability for medical affairs and/or clinical research whilst building strong relationships with all internal stakeholders
- Able to manage complexity
If you feel you have the skills, experience and interest in this role then please apply directly.
Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.