Medical Reviewer

Job Title:
Medical Reviewer/Safety Reviewer III

Location: REMOTE

Duration: 12 months with possible extension

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 the Scientific Communication Platform. Experience in large congress planning and management. Background in medical material resource creation.

• Conduct accurate and compliant medical review of medical and promotional materials, ensuring consistency with regulatory and scientific standards.
• Perform reviews using platforms such as Veeva Promo Mats and/or Med Comms; utilize CRM knowledge when beneficial.
• Rapidly learn and master new disease states, with emphasis on hematologic malignancies such as CLL and BPDCN.
• Clearly and concisely communicate rationales for review decisions to Commercial and Medical teams, fostering cross-functional collaboration.
• Lead or support the creation, review, and approval process for medical and promotional materials, including digital deployment.
• Ensure all materials meet internal legal, regulatory, and medical standards with high scientific integrity.
• Collaborate with Medical Affairs, Marketing, and Field Teams to align messaging and ensure assets reflect the latest clinical data.
• Take ownership of end-to-end congress planning and management, including:
• Acting as liaison between vendors and internal teams
• Managing timelines, feedback sessions, and budget tracking
• Overseeing the development, review, and delivery of booth materials, ensuring compliance and timely execution
• Organizing post-congress debriefs and feedback sessions
• With oversight, contribute to the development of the therapeutic area strategy.
• Contribute to all launch readiness materials

• 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. 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 (oral and written).
• 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.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”