Description:

• Title: Medical Reviewer/Safety Reviewer III (Remote)

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

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 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.

Top 3-5 skills, experience or education required for this position (in order of priority):

• Ability to work independently, with the potential to quickly onboard, because candidate has;
  • o Previous experience performing medical review of both medical and promotional materials
  • o Previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge)
  • o Previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
• Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams.

Qualifications:

• 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 on-going medical affairs projects.
• Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.

Pay Range:

• $40-45/Hr