Position Title: Medical Reviewer Work Location: Remote Assignment Duration: 12 MonthsPosition Summary: The Medical Reviewer supports the development and execution of the therapeutic area medical strategy, providing scientific, strategic, and operational input for the specific asset or indication.Background & Context:
- The Medical Reviewer has a key role within the designated Therapeutic Area, working under the leadership of the Scientific Director/Medical Directo
Key Responsibilities:
- With oversight, contributes to the development of the therapeutic area strategy.
- Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan.
- Leads conference planning and execution. Represents our organization at external meetings including investigator meetings, scientific association meetings, etc.
- May be responsible for Medical Review (MR) training for on label, clinical data, and disease state.
- Responsible for managing budget for assigned projects including consulting and vendor management.
- Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication.
- Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.
- Aligns medical education and scientific initiatives with the Scientific Communication Platform.
- Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
- Contributes to all launch readiness reviews/planning.
Qualification & Experience:
- Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
- 3-5 years of clinical, scientific/research, or industry-related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required.
- Good understanding of legal and regulatory guidelines (e.g., knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
- Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, and other applicable local regulations.
- Good understanding of Medical Affairs principles, study design, and publications.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, and experience in the design of protocols preferred.
- Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
- Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross-functional groups and have strong interpersonal and communication skills.
- Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to ongoing medical affairs projects.
- Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.