Founded in 2000, TMC is a thriving service provider organization working internationally providing a full suite of services to small/medium biotech/biopharma companies. TMC has offices in the UK, Ireland and a hub in North America (www.tmcpharma.com).
We are looking for a highly skilled and motivated Medical Affairs Director, Medical Services, to join our growing team and contribute to our mission of improving patient outcomes.
Specific duties and responsibilities of the role:
* Support and provide medical input into post marketing medical affairs services, including but not limited to medical information, medical compliance review and MSL management and support.
* Act as a Medical Signatory for the material activities received by TMC Clients and TMC itself, according to ABPI Code of Practice, and interact with country signatories/approvers for completion of material review and certification process.
* Act as Scientific Information Officer and clinical technical expert when required
* Provide medical input to TMC departments, project teams and Client/sponsors as required.
* Participate in all stages of clinical trial development and execution process (includes all aspects of medical monitoring and medical management).
* Manage/review and oversee TMC client projects in Medical Affairs and Medical Writing.
* Maintain knowledge of relevant regulations and therapeutic areas, continuing professional development, and maintaining licence to practice.
* Act as line manager for direct reports and manage appropriate training plans for the medical team.
* Participate in business development and client liaison.
* Management of the medical department including recruitment and oversight of permanent and contract employees if required.
Person Specification:
* Qualified Signatory (ABPI certification, or proven experience as a Medical Signatory)
* Exceptional interpersonal skills
* First-class administrative and organisational skills
* Proactive approach to work, demonstrating initiative and reliability
* High standard of written and spoken English, with a keen eye for detail
* Outstanding work ethic and commitment to meeting timelines without compromising quality
Essential Qualifications:
* Qualified physician (medical degree)
* GMC registration
* Medical Degree and Board Certified Specialist in Pharmaceutical Medicine Consultant and member of the Faculty of Pharmaceutical Medicine, with a broad range of industry training and experience.
Knowledge, Experience and Technical Skills:
* Qualified signatory (ABPI certification, or proven experience as a medical signatory)
* At least 5 years of senior level development / Medical positions in Pharma industry experience
* Excellent with MS Office ie, Excel, PowerPoint, etc.
* Experience working within strict protocols and guidelines
* Able to undertake some international travel depending on project needs
Desirable Skills:
Some experience of clinical practice in a relevant specialty (e.g. rare diseases, immunology, oncology, paediatric, CNS)