Senior Medical Signatory Business Partner
Overview
The Senior Medical Signatory Business Partner is accountable for leading the compliant medical review and certification of impactful, promotional and non-promotional activities and materials for Boehringer UK and Ireland whilst fully adhering to ABPI and IPHA codes, company SOPs, and relevant UK and Irish legal requirements.
Responsibilities
* Use their extensive industry, therapy area, medical and code compliance knowledge to partner with the business.
* Expertly manage code governance projects and proactively engage with stakeholders to lead the development of guidance materials.
* Employ high ethical standards, whilst managing risk, to successfully execute the commercial strategy and activities for UK and Ireland.
* Provide high level influence, mentoring and training for local and global teams in business-wide forums.
* Be responsible for training and mentoring aspiring signatories.
Accountabilities
* Provide judicious and timely medical review and approval (certification or examination) of promotional and non-promotional materials and activities to ensure successful implementation of commercial and medical projects, within assigned therapy area or above therapy areas, as assigned.
* As a leader, collaborate with, and empower cross-functional brand teams to make pragmatic and competitive code-related decisions aligned with therapy area plans, whilst managing numerous approval activities concurrently.
* Identify and proactively manage concerns about code issues that could have a high business impact.
* Lead on assigned code governance projects. Develop and update guidance materials to support the wider company on priority day-to-day copy approval topics, as well as longer term strategic topics that impact across the business.
* As the subject matter expert, maintain own knowledge of updates to codes, legislation and code precedents, and business systems and platforms related to copy approval.
* Provide leadership and advice on Intercompany Dialogue (ICD) cases and Code complaints.
Requirements
* Registered medical practitioner (GMC registered) or a pharmacist registered in the UK.
* Qualified Medical Signatory notified to the PMCPA and MHRA.
* Hold a licence to practice with the GMC, undergoing revalidation and continued demonstration of fitness to practice (for UK GMC registered physicians).
* Highly recommended to have specialist accreditation in Pharmaceutical Medicine, as denoted by entry on the GMC specialty register.
* Extensive experience in the pharmaceutical industry as a qualified Medical Signatory, preferably in a medical adviser or medical signatory leadership role.
* Extensive experience with application of the ABPI and IPHA codes.
* Ability to identify, understand and manage complex problems within and across diverse teams.
* Excellent communication, collaboration, networking and influencing skills.
* Project management skills.
* Ability to manage conflicting priorities.
* Proven record of successful management and participation in company code-education and discussion forums.
* Strong understanding of the external environment, the NHS, Government policy, regulatory requirements.
* Ability to work in fast-paced, complex environment and quickly assimilate medical data and concepts.
* Team-oriented, able to develop and support relationships across the organisation.
* Willing to educate colleagues and share knowledge.
* Proven record of successful leadership in the complaint process.
* Demonstrated capability to work as a strategic business partner within an organisation.
* Mentoring and coaching skills.
* Strong commitment to ethical compliance and integrity.
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