Medical Reviewer/Safety Reviewer III

Job description:
Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials and non-promotional materials . Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Ensures deliverables convey a clear and appropriate medical message.
Responsibilities:

• Medical review of promotional and non-promotional materials across multiple indications for one product.
• Maintains expert understanding of product knowledge and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics for assigned therapeutic area(s). As necessary, assumes responsibility for diverse and/or complex projects regardless of therapeutic area.
• In an independent manner, critically evaluates literature, interprets complex data, writes effectively, articulates information to a variety of audiences, and effectively negotiates with counterparts from cross-divisional functional areas.
• Functions independently in timely decision-making while considering the broader impact to the organization. Confidently executes on and communicates decisions and rationale.
• Acts as a subject matter expert to internal customers or appropriate stakeholders to provide them with timely up-to-date scientific and clinical information necessary to make impactful business decisions.
• Independently anticipates risk and implements strategies to avoid potential problems. Independently resolves higher risk or complex issues having the potential for financial, legal or regulatory implications.
• Recommendations, actions and decisions made are critical to ensure compliance with applicable regulatory standards pertinent to the promotion of pharmaceutical products. The actions of this position impact decision-making regarding company products with respect to patient safety and prescribing behavior.

Requirements:

• Bachelor's degree. Graduation from an accredited Nursing, PA, Pharmacy, PhD in Health Sciences, or equivalent experience.
• Achieved licensure for professional practice, if appropriate for field.
• Minimum of 2 years of Medical Review experience.
• 6 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience with 4 years' work experience or postgraduate training in Medical Communications or related Medical Affairs experience preferred.
• Strong critical thinking skills to identify medical issues, suggest alternatives, and negotiate effective solution.
• Strong ability to independently function in Medical Review role.
• Oncology Experience.