Medical Reviewer/Safety Reviewer III
- 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.
job type: Contract
salary: $45.00 - 51.17 per hour
work hours: 9 to 5
education: Masters responsibilities:
- 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 PromoMats and/or MedComms; utilize CRM knowledge when beneficial.
- Rapidly learn and master new disease states, with particular emphasis on relevant hematologic malignancies therapeutic areas like 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:
- Coordinating logistics (booth content, registration, hotel/travel arrangements, EE meeting logistics, etc.)
- 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
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 (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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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