Sr. Manager Medical Affairs Project Management & Operations

The Immunology & Inflammation ( I&I ) Global Medical Franchise ( GMF ) Strategic Business Planning & Execution ( SBP&E ) is seeking a Senior Manager to provide strategic & operational project management excellence to the I&I GMF Therapeutic Area ( TA ) Heads & Medical Directors under the franchise.

This position will work cross functionally (medical, commercial, development) but also, across companies (Regeneron, Sanofi Alliance) to compliantly influence in a most collaborative way, negotiating in support of Regeneron’s Scientific Share of Voice securing positive patient outcomes.

As a Sr Manager, Medical Affairs Project Management & Operations you will provide project management support to the Global Medical Affairs Head and Medical Directors for our Immunology Franchise.

You will support the strategic and tactical planning, budget preparation, management, forecasting, accrual management.

Additionally, you will be responsible for the planning & management of project team meetings, adboard preparation & execution, and operational business needs.

As part of this Medical Affairs team you will drive process improvement initiatives as needed. Ensures optimal execution of the Medical Affairs Product Plans (MPPs) and manage cross-functional collaborations with our internal and external alliance partners.

A typical day may include the following :

Supporting TA Heads & Medical Directors within the Franchise owning the execution of Global & US Medical Affairs tactics as defined in the Medical Impact Plans.

Collaborating effectively and positively with Global Clinical Operations, the Alliance & other functional areas as applicable.

Conducting kickoff, core team, and line function meetings.

Translating key project deliverables and strategic program imperatives resulting in seamless execution.

Working with Therapeutic Leads and HEOR Lead / PM on priorities and ensure efficient execution in alignment with strategic approach.

Accountable for managing project budgets, coordinating operational plans and budgets working in collaboration with Finance.

Providing project-related support to all process-related aspects with regards to the implementation and execution of publication plans, advisory boards, expert consultations, steering / scientific committees and management of outside vendors.

Ensuring compliant execution of all Medical Affairs activities and assists with the review and development of departmental procedural documents in accordance with Agency regulations and guidance.

Ensuring well-aligned and effective collaboration between internal Regeneron functions and business partners relevant to the US and Global franchise teams.

Supporting the execution and building of strategic needs around business process improvement needs and crafting adequate platforms to support current and future business needs.

This may be for you if :

Can demonstrate an analytical approach to problem solving and evidence-based decision making

Have collaborated at all levels in the organization, including interfacing at the senior management level.

Demonstrate ability to translate & present complex (scientific) information to others effectively.

Want to make a difference in patient lives.

To be considered for this, you should have a Bachelor’s Degree with 7+ years’ experience working in healthcare / pharmaceutical / biotechnology field working knowledge of drug development.

An advance degree and PMP certification is preferred. The position requires strong knowledge of applicable regulatory agency regulations, guidelines and / or specifications (eg.

FDA, EMA, ICH). Experience initiating and leading large, cross-function projects through to completion. Experience with Early Phase assets would be helpful.