Manager, Medical Affairs Operations
1 day ago
POSITION: Manager, Medical Affairs Operations
The salary range for this position is between $120k and $140k.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience. The company also currently offers a Long-Term Incentive Plan (cash plan) of 15% base salary, annual performance bonus target of 15% base salary (subject to meeting plan requirements) and comprehensive health benefits (employer funded), unlimited vacation time and 401k plan (subject to change or modification from time to time).
POSITION SUMMARY
The Manager of Medical Affairs Operations will be responsible for key functions such as budget management, contract administration, transparency reporting, compliance documentation, and SOPs, as well as managing grant and Investigator-Initiated Studies (IIS) committees. With a focus on ensuring streamlined processes, standardized documentation, and adherence to compliance requirements, the manager will lead Medical Affairs operations to facilitate coordination among various stakeholders. The ideal candidate will have to possess strong project management skills, exceptional organizational abilities, and experience managing large budgets as it will interface with all aspects of Medical Affairs, cross-functional partners, and external stakeholders. This position will report to the Senior VP of Medical Affairs & Drug Safety US.
KEY RESPONSIBILITIES
- Collaborate with other MA functional areas (e.g., Field Medical & Publications, HEOR, MI, etc.) and provide project management support, and tools including overseeing the MA Dashboard.
- Contribute to the development and maintenance of MA documents (archive, register on CRM, etc.). Manage and optimize Medical Affairs systems and databases.
- Serve as the primary contact for the Finance department within Medical Affairs, responsible for drafting the annual budget in partnership with the Medical Leadership Team, and manage monthly accrual processes along with reconciliation and close-out to ensure proper data entry and reporting.
- Track and manage IITs and GRANTs submissions through internal processes. Follow up to ensure successful execution of the programs and individual studies.
- Provide operational oversight of vendors as required.
- Author and/or review MA Standard Operating Procedures (SOPs). Develop and implement training programs related to MA operations, SOPs, and compliance. Identify opportunities for process efficiencies and continuous improvement.
- Act as a liaison between Medical Affairs and Legal, Compliance, Regulatory, and Commercial teams to align processes and ensure smooth operations.
- Perform other duties as assigned.
QUALIFICATIONS, CAREER EXPERIENCE AND SKILLS
A combination of relevant education and applicable job experience will be considered.
Qualifications and Career Experience
- Bachelor's degree in business, Life Sciences, or related field. Master's degree preferred.
- 5+ years of experience in pharmaceutical operations, medical affairs, or a related field.
- Strong understanding of contract management, budgeting, and compliance standards within the pharmaceutical industry.
- Proven ability to manage complex projects and cross-functional collaborations.
- Excellent organizational, analytical, and communication skills.
Preferred Skills
- Experience with transparency reporting systems.
- Knowledge of grants and IIT processes.
- Proficiency in document management systems and archiving best practices.
- Strong problem-solving and decision-making abilities.
ETHICS AND COMPLIANCE
- Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor.
- High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers.
- Always operates in compliance with all applicable regulations and professional standards.
TRAVEL
- The ability to travel up to 20%, including overnights and internationally, as dictated by business need.
VALUES & BEHAVIORS
- Live Entrepreneurship: Plan for long-term growth and build a future business predicated on innovation.
- Patient Centric: Deliver innovation for patients and challenge each other to improve patient outcomes.
- Join Forces: Seek diverse input, collaborate across all functions, and leverage resources from global partners.
- Act with Integrity: Apply ethical standards, encourage transparency, and embrace diversity and inclusivity.
- Drive Performance: Create an atmosphere that nurtures teamwork in order to enable high performance and sustainable growth.
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