Associate Director, Medical Affairs-Strategic Business Planning & Execution,

Regeneron Pharmaceuticals•Sleepy Hollow, WY

7d•$157,200 - $256,600•Onsite

About The Position

The Associate Director, Medical Affairs Strategic Business Planning & Execution provides project management support to the Global Medical Affairs Head and Medical Directors within our Neurology Franchise. As the key operational member you will seamlessly interact cross-functionally with all related Product Committees for information sharing, issue escalation, and resolution. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

A Bachelor’s Degree with 10+ years experience, an MBA with 8 years or an advanced degree with 5+ years experience (preferred).
Active working experience in the pharmaceutical/biotechnology field as a project manager in Clinical Development is required.
Requires strong knowledge of applicable regulatory agency regulations, guidelines and/or specifications (FDA, EMA, ICH).
Ability to initiate and lead large, cross-function projects and see it through to completion.
Demonstrated project management skills.

Nice To Haves

Experience with medical affairs or launch experience is preferred.
PMI Certification preferred

Responsibilities

Drive the execution of Global and US Medical Affairs tactics as defined in the Medical Product Plans
Schedule and facilitate team meetings for decision making, achieving project goals and updating the current status of projects within the desired timeline, resources, and budget.
Create and maintain strong collaborations with internal and external partners; including but not limited to: Global Development, Medical Operations and Commercial.
Owns integrated medical tactical plans, track progress and reports out status on progress. Ensures ownership for completion of all tactics on time, scope and within budget
Facilitates the identification and resolution of risks, delays and or changes on the tactical execution
Oversight of all Ph IV, Registry, IIS & Strategic Collaboration Studies in terms respective progress per timelines and budget
Manage operational plans and associated budgets working in collaboration with Finance.
Provide project-related process support for implementation and execution of publication and communication plans, advisory boards, expert consultations, steering committees and management of vendors.
Serve as a key liaison between Medical Affairs and external vendors.
Develop and drive new processes and tools to ensure vertical and horizontal integration across functional areas.
Identify new tools and resources, and act as an ambassador for all systems and tools, including AI.
Identifies and communicates business process enhancement needs or technical issues to management and Global Development Systems.
Ensures compliant execution of medical affairs activities. Assists with reviewing and developing departmental procedural documents in accordance with SOPs, regulations and guidance’s.