Medical Reviewer

Job Title: Medical Reviewer/Safety Reviewer III Location: REMOTE Duration: 12 months with possible extension Job description:

• 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
• Experience in large congress planning and management
• Background in medical material resource creation What are the top 3-5 skills, experience or education required for this position (in order of priority):
• Medical review expertise: Previous experience with medical and promotional materials, ideally in Veeva PromoMats and/or MedComms. Knowledge in CRM is beneficial.
• Therapeutic area experience: Direct experience in CLL or other relevant hematologic malignancies (eg, BPDCN or others) therapeutic areas, along with a track record of quickly mastering new disease states.
• Congress planning and management: Demonstrated experience acting as a liaison with vendors and internal teams for congress management (booth content, registration, EE meeting logistics, etc.).
• Communication skills: Ability to clearly and concisely articulate rationales for review decisions, especially when collaborating with Commercial and Medical Teams.
• (Preferred) Medical education creation: Experience in developing medical material resources and digital medical education is a plus. Purpose The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific 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 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. They will ensure accurate and compliant medical review of medical and promotional materials within relevant hematologic malignancies therapeutic areas (such as CLL, BPDCN, or others). They act as a liaison for congress planning and management, coordinate with vendors and teams, and organize debriefs and feedback sessions post-congress to capture learnings and optimize future events. Additionally, they may contribute to the creation of medical material resources and digital medical education, helping support organizational commercial and medical objectives. Responsibilities 1. Conduct accurate and compliant medical review of medical and promotional materials, ensuring consistency with regulatory and scientific standards. 2. Perform reviews using platforms such as Veeva PromoMats and/or MedComms; utilize CRM knowledge when beneficial. 3. Rapidly learn and master new disease states, with particular emphasis on relevant hematologic malignancies therapeutic areas like CLL and BPDCN. 4. Clearly and concisely communicate rationales for review decisions to Commercial and Medical teams, fostering cross-functional collaboration. 5. Lead or support the creation, review, and approval process for medical and promotional materials, including digital deployment. 6. Ensure all materials meet internal legal, regulatory, and medical standards with high scientific integrity. 7. Collaborate with Medical Affairs, Marketing, and Field Teams to align messaging and ensure assets reflect the latest clinical data. 8. Take ownership of end-to-end congress planning and management, including: o Coordinating logistics (booth content, registration, hotel/travel arrangements, EE meeting logistics, etc.) o Acting as liaison between vendors and internal teams o Managing timelines, feedback sessions, and budget tracking o Overseeing the development, review, and delivery of booth materials, ensuring compliance and timely execution o Organizing post-congress debriefs and feedback sessions 9. With oversight, contribute to the development of the therapeutic area strategy. 10. Contribute to all launch readiness materials 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 r

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