Job Responsibilities:
- Coordinate and facilitate Senior Medical Review Committee (MRC) meetings for discussion and approval of Scientific Exchange Materials (per MRC SOP 054).
- Schedule weekly MRC meetings and manage the review schedule.
- Liaise with team members and Document Owners to identify agenda items and ensure agenda items are met.
- Facilitate discussion during MRC meetings to ensure all agenda items are addressed.
- Liaise internally with functional departments and externally with vendors as needed.
- Provide strategic planning, manage resources, and track MRC meeting milestones.
- Partner with Medical Affairs Leadership Team to develop, execute, and monitor review/approval plans and tactics for Medical Exchange Materials.
- Identify MRC risks and implement/manage mitigation plans.
- Keep stakeholders informed of important changes while driving review/approval projects.
- Develop and improve MRC project planning and monitoring tools.
- Anticipate problems and translate solutions into viable global action plans implemented with stakeholder cooperation.
Supervisory Responsibilities:
- None.
Education/Experience Qualifications:
- Bachelorβs degree in a related discipline and at least 9 years of related experience; or equivalent combination of education and experience.
- Typically requires 7 years of related experience and/or combination of experience and education/training.
- Minimum 5 years overall experience in biopharmaceutical/biotech; at least 3 years in a Medical Affairs role.
Knowledge/Skills (Required):
- Comprehensive knowledge in relevant industry/profession and specialization.
- Strong analytical and business communication skills.
- Ability to apply professional concepts and company objectives to resolve complex issues creatively and effectively.
- Identifies and implements methods/procedures to achieve results.
- Ability to influence others and guide teams, with responsibility for results (including costs, methods, and staffing).
- Performs complicated tasks with creativity and latitude.
- General knowledge of related disciplines.
Benefits (as stated):
- Base pay range: $170,000β$242,000 annually.
- 401k with company contributions; group medical, dental, and vision; life and disability; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Opportunity to purchase company stock; long-term incentives.
- 15 vacation days (first year); 17 paid holidays (including winter shutdown in December); up to 10 sick days.
Working Conditions:
- Primarily indoor/clerical work.