Medical Reviewer/Safety Reviewer III

Pay range: 34-44/hr
*depending on experience

Description:

The primary responsibilities would include

• Medical Review for label, clinical data and disease state
• Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews
• Aligns medical education and scientific initiatives with Scientific Communication Platform

What are the top 3-5 skills, experience or education required for this position (in order of priority):
1. Ability to work independently, with the potential to quickly onboard, because candidate has…
a. ...previous experience performing medical review of both medical and promotional materials
b. ...previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge)
c. …previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
2. Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams

Purpose
The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation, this leader ensures tactical execution is relevant to the market– physicians, patients and payors.
Responsibilities
1. With oversight, contributes to the development of the therapeutic area strategy.
2. 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.
3. Leads conference planning and execution. Represents at external meetings including investigator meetings, scientific association meetings, etc.
4. May be responsible for Medical Review (MR) training for on label, clinical data and disease state.
5. Responsible for managing budget for assigned projects including consulting and vendor management.
6. Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication
7. Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.
8. Aligns medical education and scientific initiatives with the Scientific Communication Platform.
9. Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
10. Contributes to all launch readiness reviews/planning.

Qualifications - External
1. Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
2. 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.
3. Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
4. 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
5. Good understanding of Medical Affairs principles, study design and publications.
6. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
7. Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
8. 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.
9. Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
10. Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.