Medical Reviewer/Safety Reviewer III
Katalyst CRO - Worcester
Work at Katalyst CRO
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Overview
Join to apply for the Medical Reviewer/Safety Reviewer III role at Katalyst CRO Continue with Google Continue with Google 3 months ago Be among the first 25 applicants Join to apply for the Medical Reviewer/Safety Reviewer III role at Katalyst CRO 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. 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Health Care Provider Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Continue with Google Continue with Google Medical Assistant (Geriatrics) 40 Hours, Days Medical/ Clinical Genetic Review Specialist Massachusetts, United States $55.00 - $55.00 3 weeks ago Medical Assistant, Endocrinology, 40 Hours, Days Medical Assistant (Family Docs Of Worcester) 40 Hours, Days Medical Assistant - 4.5 days/week - Pediatrics Certified Medical Assistant/Medical Assistant Certified Medical Assistant/Medical Assistant - Urgent Care Medical Assistant, Neurosurgery Clinic, 40hr days Medical Assistant (Northboro), 40 Hours, Days Certified Medical Assistant/Medical Assistant - Urgent Care Medical Assistant, Neurosurgery Clinic, 40hr days Westborough, MA $16.51 - $22.19 1 week ago Reimbursement Authorization Specialist @ Ajinomoto Cambrooke Urgent Care Center Medical Assistant/Coordinator Medical Assistant, Arthritis and Joint Center - 40 hours, Days Medical Assistant, Community Womens Care, Per Diem Certified Medical Assistant/Medical Assistant (New Patient Services) Join Our Team as a School Nurse – K–12 Role in Whitinsville, MA Medical Assistant, Hopkinton Primary Care, 28 hours We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr