- Oversee the end-to-end MLR review process for all materials, ensuring compliance with internal and external policies and regulations.
- Schedule, set agendas, and lead Review Committee meetings, ensuring that all materials undergo proper review in the online system (e.g., Veeva Vault PromoMats and Vault MedComms).
- Add live discussion notes during meetings and ensure that all comments are documented accurately.
- Draft, circulate, and finalize meeting minutes for approval, ensuring all records are filed and archived appropriately.
- Verify that all submitted materials are complete and properly assigned to the correct review path, rejecting incomplete or unreview-ready submissions.
- Conduct quality checks to compare the final document to the approved version.
- Support FDA 2253 submissions in partnership with the MLR Regulatory Reviewer.
Medical Content Support
- Assist with the development of project plans and provide administrative support for the medical content team.
- Support the upload of materials into clients review and approval platforms, including annotation and referencing.
Medical Affairs Project Management
- Assist the Medical Affairs and Medical Information teams in the management and execution of project plans for key initiatives.
Job Expectations
- Metrics: Contribute to process improvements that positively impact MLR review metrics.
- Customer Service: Maintain and improve service quality related to MLR review activities.
- Time Management: Ensure timely completion of all MLR coordination tasks.
- Hours: Full-time position with flexibility in scheduling to accommodate client and management needs.
- Travel: This position does not require travel.
QualificationsRequired
- Education: Bachelors degree in a Life Sciences or Biomedical field.
- Experience: At least 2 years of experience in a healthcare agency or pharmaceutical company, with a focus on MLR review processes.
- Skills:
- Proficiency inVeeva Vault PromoMats/MedComms.
- Strong project management, time management, and meeting management skills.
- Excellent customer service skills, with the ability to communicate effectively in both written and oral forms.
- Computer proficiency inMicrosoft Office Suite(Outlook, Word, Excel, PowerPoint).
Preferred
- Education: Postgraduate degree in Pharmacy, Medicine, or related field.
- Experience:
- Familiarity with global healthcare compliance laws and regulations, particularly in drug/device advertising and promotion.
- Previous experience with scientific writing or reviewing in an MLR context.
- Skills:
- Ability to manage cross-functional projects and prioritize tasks effectively.
- Knowledge of medical terminology (preferred but not required).
Cultural Beliefs at EVERSANA
- Patient Minded: We act with the patient s best interest at heart.
- Client Delight: We take ownership of every client experience and its impact on results.
- Take Action: We are empowered and accountable for our actions.
- Embrace Diversity: We foster an environment of respect and inclusivity.
- Grow Talent: We own our development and support the growth of others.
- Win Together: We collaborate across boundaries to achieve our goals.
- Communication Matters: We ensure transparency through thoughtful and timely communication.
- Always Innovate: We are bold and creative in everything we do
