The Senior Legal Counsel to US Medical Affairs will be providing strategic legal advice to the US Medical Affairs Leadership Team (MALT), including advising US Country Medical Director as well as other functions that make up US Medical Affairs (US Medical Therapy Areas (Respiratory, Oncology & Specialty), Customer Engagement and Value Evidence Outcomes, Medical Engagement Capabilities & Enablement, Medical Information, and Safety Governance & Quality Risk). As legal counsel for MALT you will be dealing with a wide range of legal issues that span the life cycle of a pharmaceutical asset.
Key activities and responsibilities of this role will include:
- Member of MALT, advising the US Country Medical Director and other members of MALT
- Reviewing scientific documents, press releases and medical business plans and advise on appropriate strategy/language to manage legal risk while maximizing Medical engagement.
- Providing strategic advice to TA Medical teams regarding Medical activities with HCPs, Payers, and patients.
- US Legal lead for HCP/EE Medical Engagement, including MSL/HOL activities and support of US HCP Engagement Hub.
- Counsel on appropriate interfaces between Commercial/Marketing and Medical
- Providing advice to US Value Evidence Outcomes, including contracting, USHO Collaborative Studies, RWE trial issues and use of HealthCare Economic Information with Payers and Formulary Decision Makers.
- Supporting Investigator Supported Studies.
- Counseling on US Pharmacovigilance issues
- Reviewing and advising on US Medical Affairs Grants and Donations
- Providing legal advice to Medical Information, regarding content of medical responses as well innovative channels for distribution of medical information
- Partnering with Compliance, including conduct of investigations of alleged compliance violations, training for US MALT and other relevant stakeholders, and creation and review of current US policy and SOPs to enable effective Medical internal and external engagement.
- Position will require you to work in a matrix setting with various stakeholders in Legal (USLO and RDLO) as well as within the US Business. Will also interact with senior leaders in Legal, Medical and the US Pharma Business.
This position will be based in the US (either RTP or Philadelphia) and will report to Head of Legal Global Medical. Expected travel will be minimal (< 20%).
We are looking for professionals with these required skills to achieve our goals:
- J.D. with Bar Qualification
- Experience in Pharmaceutical Law, Life Science/Healthcare Law, Corporate Law
- Experience working with Medical Affairs groups within Pharma
- US experience in non-promotional and promotional activities
- Strategic thinker who is able to provide practical resolutions and help resolve conflicts.