Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
About the role
- Associate Principal Scientist responsible for evidence strategy and planning in Women's Cancer at Merck. Engaging in cross-functional collaboration to assess medical value and reimbursement strategies.
Responsibilities
- Support value evidence teams in Women’s Cancer and contribute to value evidence strategies.
- Obtain senior management approval of evidence generation plans.
- Provide outcomes research expertise on cross-functional regional and global teams.
- Critically assess drivers and barriers to reimbursement and market access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.
- In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.
- Responsible for study-related contracting, and budgets.
- Develop supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies.
- Support country affiliates to understand local evidence generation needs, adapt health economic evaluations, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.
- Work closely with cross functional teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.
- Maintain awareness of new scientific and methodological developments within therapeutic area.
- Build relationships with scientific experts worldwide.
- Present outcomes research data at national and international congresses and publish articles in scientific journals.
Requirements
- Master’s Degree from a recognized school of medicine, public health, management, pharmacy, or economics is required
- Doctoral degree from a recognized school of medicine, public health, management, pharmacy, or economics is strongly preferred
- Minimum of 5 years of experience in the design and implementation of clinical, epidemiological, or health economic studies
- Doctoral degree with 3+ years relevant experience or doctoral training preferred
- Demonstrated expertise in the field of outcomes research, epidemiology or health economics preferred
- Excellent leadership and strategic thinking skills
- A track record of scientific presentations and publications.
- Real-world evidence experience in oncology
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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