Sr. Specialist, Medical Affairs Strategic Operations - REMOTE

** Job Description
** Reporting to the Head of Strategic Operations and Chief of Staff (CoS) for the Vice President of Medical Affairs Outcomes Research (MAOR), the Senior Specialist will support the work of the Strategic Operations team. This includes but is not limited to: (1) Management of the review process for non-interventional studies, independent publications, local data generation and investigator-initiated studies (2) Ongoing oversight of investigator-initiated studies (3) Management of Independent Medical Education grants (US only).
** Primary Responsibilities
*** Manage the Non-registrational Study Approval Process (NORSAP) for all therapeutic areas including coordinating the meetings, taking minutes, and follow up post meeting as required
* Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee
* Ongoing management of approved Investigator Initiated Studies (IIS’s) including (but not limited to) contracting, drug supply, study tracking, and close out
* Oversees and executes on the end to end US Independent Medical Education grants review and approval process including facilitation of Review Committee Process
* Maintains knowledge of organizational strategic focus, inter-departmental activities, current clinical and scientific concepts, internal and external governing policies, and adult-learning modalities in medical education, contract negotiation and interpretation, budget and project management, and vendor management
* Maintains financial and/or organizational priorities maintaining appropriate processes and financial controls to ensure completion of programs within established budgets
* Ensures compliance with existing internal and external guidelines as they pertain to professional relations, patient advocacy, Investigator Initiated Studies and Independent Medical Education, as well as Organon’s internal standards based on its interpretation of the applicable laws and regulations
* Actively manage the successful and compliant contracting, payment and tracking process
* Engages in special projects and other duties as assigned
** Skills
* ** Excellent interpersonal communication skills. Ability to problem solve, critical thinking skills. Good written communication skills
* Experience with Microsoft Excel, PowerPoint and Word
** Experience
* ** At least 3 - 5 years of operations support in Pharma or similar background
* Vendor Management
* Preferred experience with Investigator Initiated Study Management
* Preferred experience with Independent Medical Education (US)
** Education
* ** Educational Requirement:
Bachelor’s degree in business or similar#LI-Remote
*
* Who We Are:

** Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  

Our Vision is clear: A better and healthier every day for every woman.
** US and PR Residents Only
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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
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