Job Summary

The Scientific and Medical Research Writer is responsible for scientific evidence-based research, assessment, and written reports within the Vigilance Department, including but not limited to Health Hazard Evaluations, Special Memos, and Regulatory Annual NDA Report Sections. Incumbent investigates, research and compiles reports and health risk assessments of our products to meet health hazard evaluation compliance commitments. Provides scientifically balanced medical and scientific information on company products to external and internal customers. Incumbent also devises strategies, performs literature searches, and compiles Clinical and Non-Clinical Summaries on company NDA products for FDA, NDA, and Annual Regulatory Reports.

Responsibilities

• Responsible for scientific evidence-based literature review, research, and written reports incorporating medical, clinical, toxicologic, scientific, epidemiological, and pharmacologic information and assessments for the Vigilance, and Quality Departments, in support of Fresenius-Kabi USA products.
• Develops PubMed-based search strategies and performs research and compilation of Clinical and Non-Clinical summaries for contribution to Regulatory NDA Annual Reports for submission to the FDA.
• Responsible for the provision of Health Hazard Evaluations within local and regulatory timelines. Supports the National Safety Officer and Vigilance Department Management in assessment of patient safety risk. Collaborates with US Manufacturing, Quality, and Regulatory Departments to resolve safety and quality issues.
• Compiles, analyzes, and interprets potential toxic substances; obtains toxicological, biological, microscopic, and chemical data and reports conclusions.
• Develops criteria and rationale for assessing health hazards, incorporating toxicology, clinical, drug safety, and quality aspects of cGMP manufacturing of pharmaceutical products.
• Investigates and researches potential health hazard signals. Evaluates potential patient risks arising from product quality complaints, and deviations.
• Maintains knowledge of and utilizes relevant current ICH, USP, and FDA Guidance Documents.
• Researches and develops FK USA Pharmacovigilance position papers or memos as needed.
• Contributes with due diligence materials for quality investigations and business development opportunities as needed.
• May participate in writing and/or review of relevant Standard Operating Procedures (SOP’s) as needed.
• Develops Risk Management Plans (RMPs) upon request.
• Researches and develops FK USA Pharmacovigilance position papers as needed.
• Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
• Additional tasks and responsibilities as required.

Requirements:

·        Advanced degree (MS, or PhD in a relevant science field) required.

·        PhD +1 year or MS +3-5 years of experience in the pharmaceutical industry, toxicology, drug safety or pharmacovigilance role, product development role, or an academic or clinical research role, required.

·        Candidate with Medical/clinical professional degree (PharmD, RPh) and appropriate research experience may be considered.

·        Pharmacology and Toxicology knowledge required.

·        Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents.

·        Clinical experience or experience in a biomedical field preferred.

·        Adverse drug event review and product information experience preferred.

·        Ability to understand and interpret federal regulations and company operating procedures as it applies to a medically complex adverse drug event and determine whether the event constitutes a potential product quality issue.

·        Ability to interpret large amounts of safety and quality-related data and recognize/identify, and when possible, quantify, potential health hazards.

·        Experience with adverse drug event software is preferred. Knowledge of the ARISglobal database is a plus.

·        Must be able to prioritize, have a sense of urgency, and multi-task with minimal supervision.

·        Excellent written and verbal communication skills required.

Knowledge of PC systems and Microsoft O