Job Title: Program Manager, Evidence Generation & Operations
Rockville, MD United States
Program Manager, Evidence Generation & Operations
The Program Manager, Global Evidence Generation Operations under direction of the Director, Global Medical Affairs Operations and Research is responsible for supporting the Global Medical Affairs (GMA) team in the planning, execution, and close-out of a variety of strategic and tactical projects. Primary responsibilities will include, but are not limited to, facilitating and managing complaint Global Evidence Generation Strategic Review (GEGSR) processes within the GMA management system, tracking progress and output of global evidence generation activities, supporting coordination, execution and tracking of key strategic tactics and playing key role in process improvement across the Global Medical Affairs department.
Key Job Responsibilities
Manages GEGSR program within the Global Medical Affairs management system through planning, executing, documenting, monitoring activities and communicating status updates, course corrections, timelines, milestones, and program metrics.
Manages the planning, coordination, and execution of monthly GEGSR program meetings
Supports the coordination, execution, tracking, and reporting of strategic tactics for global products
Supports Global Medical Affairs quarterly forecasts, manages scope, timeline and financial changes through tracking variances at the program level by cross-functional interaction with global medical teams
Manages storage and dissemination of global medical affairs product materials, including but not limited to, core medical decks, strategic decks, ad board decks, symposia decks, and frequently asked questions.
Collaborates with all functions globally including administrative, clinical, finance, legal, government affairs, safety, medical, operations, EQC, and regulatory - to lead as appropriate and support Global Medical Affairs projects.
Knowledge, Skills, Competencies, Education, and Experience
BS or BA Degree required
6+ years of project management experience (direct or supporting function) is required; project management experience in the pharmaceutical environment is required
Project Management Professional Certification or equivalent required
Ability to understand and interpret regulations, guidelines governing medical education and medical affairs operations (e.g. GMP, PhRMA, FDA, OIG, ACCME, Advamed)
Excellent interpersonal and communication skills required
Must possess proficiency in Microsoft Word, Excel, Visio and PowerPoint
Knowledge of accounting principles is a plus
Must be well organized and able to multi-task in a fast-paced deadline driven environment
Ability to prioritize workload and makes an accurate determination of timeframe for projected completion
Effectively communicates with team members and stakeholders regarding medical affairs operational activities
Asks appropriate questions in order to ensure that expected outcomes are achieved
Medical Affairs management system experience is preferred, but not required
Physical Demands and Work Environment
Travel (approximately 15%)
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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