ProClinical is partnering with an internationally renowned pharmaceutical company with leading products across various therapeutic areas. The company is seeking to fill a vacancy for a Global Medical Affairs Nominated Signatory Leader position, based in their office in Cambridge. This is an excellent opportunity for an experienced applicant to provide leadership and progress their carer with a top global organisation.
The Global Medical Affairs Nominated Signatory Leader will apply medical governance within the designated therapeutic area and drive excellence through focus on medical quality and standards and guide marketing and medical activities in a compliant and ethical manner. They will provide training for medical teams and nominated signatories according to business needs. Furthermore, they will advise on, review, and approve materials and events designed and produced by Global Brand teams with respect to Company standards, including the Global Policies on Ethical Interactions. Finally, the GMA Leader will provide information on company products as well as the regulatory requirements and applicable external codes including the IFPMA code.
Job Responsibilities:
- Acting as the company's authority and leader on medical quality and standards for the
allocated therapy area. This includes promotional claims acceptability (including avoiding
off-label claims), interacting with healthcare professionals, cross border digital activities,
medical ethical acceptability, and other matters within the scope of the IFPMA Code of
Pharmaceutical Marketing Practices. - Leading the company approach and tone for medical standards within the designated
therapy area; ensuring that the importance is recognised and integrated into everyday
business while avoiding unnecessary inhibitions to creativity and actively supporting
innovation through deep understanding of the regulations. - Supporting Marketing, Regional, and Global Marketing and Medical colleagues through training.
- Supervising the application of relevant Global Medical policies and SOPs within the allocated
therapy area. - Pro-actively and reactively working with the Marketing Company Nominated Signatories,
providing help and guidance on difficult approval issues relating to their allocated
therapeutic areas. - Support the Global Medical Standards Practice Director in knowledge sharing between Global, Regional and Marketing Company stakeholders regarding optimising brand messages and claims within the codes, regulatory and ethical constraints.
- Working with and managing relationships with the outsourced vendor so that internal colleagues act in unison.
- Setting standards for promotional claims and non-promotional product information sharing, ensuring the company's promotions and communications adhere to regulations, and supporting the appropriate use of our medicines in patients as well as driving business goals.
- Identifying future compliance and quality risks from commercial and promotional innovation within the Therapeutic Area.
- Collaborating with the Global Medical Standards Practice Director to create effective and practical medical quality policies and standards to ensure continued commercial success in a compliant and ethical manner.
Skills and Requirements:
- An advanced bioscience or pharmacy/medical qualification.
- Demonstrable experience in the pharmaceutical industry, including medical affairs and compliance.
- Good scientific understanding of the allocated therapeutic area.
- Sound knowledge of international medical compliance legislation, codes of practice and
- their practical application.
- Knowledge and experience of corporate governance.
- 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.
- Prepared to work hard to meet ambitious deadlines and exceed clients' expectations
- Proficiency in MS Office.
To Apply:
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 Tom Russell at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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