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: management of the review process for non-interventional studies, independent publications, local data generation, and investigator‑initiated studies; ongoing oversight of investigator‑initiated studies;

and management of Independent Medical Education grants (U.S. only).

• Manage the Non‑registrational Study Approval Process (NORSAP) for all therapeutic areas, coordinating meetings, taking minutes, and following up post‑meeting as required.
• Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee.
• Oversee ongoing management of approved Investigator‑Initiated Studies (IIS), including contracting, drug supply, study tracking, and closeout.
• Oversee and execute the end‑to‑end U.S. Independent Medical Education grants review and approval process, including facilitation of the Review Committee Process.
• Maintain knowledge of organizational strategic focus, inter‑departmental activities, current clinical and scientific concepts, internal and external governing policies, adult‑learning modalities in medical education, contract negotiation and interpretation, budget and project management, and vendor management.
• Maintain financial and organizational priorities, appropriate processes, and financial controls to ensure completion of programs within established budgets.
• Ensure compliance with existing internal and external guidelines as they pertain to professional relations, patient advocacy, investigator‑initiated studies, Independent Medical Education, and Organon’s internal standards based on applicable laws and regulations.
• Actively manage the successful and compliant contracting, payment, and tracking process.
• Engage in special projects and other duties as assigned.

• Excellent interpersonal communication skills, including problem‑solving and critical thinking, and strong written communication abilities.
• Proficiency with Microsoft Excel, PowerPoint, and Word.

• At least 3–5 years of operations support in Pharma or a similar background.
• Vendor management experience.
• Preferred experience with Investigator‑Initiated Study Management.
• Preferred experience with Independent Medical Education (U.S.).

Bachelor’s degree in business or a related field.

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.

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.

Organon LLC does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid if a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place.

Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range (U.S.): $ – $. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Employee Status:
Regular.
Number Of Openings: 1.

Requisition : R538950.
Relocation:
Not specified.
Visa Sponsorship:
Not specified.
Travel Requirements:
Must satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Not specified.
Valid Driving License:
Not specified.
Hazardous Material(s):
Not specified.