Medical Reviewer/Safety Reviewer III

• 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

Top 3-5 skills, experience or education required
• 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.

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 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 (oral and written).
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.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.