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Assoc Prin Scientist, Regulatory Liaison
About the position Associate Principal Scientist Regulatory Affairs- Oncology At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in the lives of patients globally. Responsibilities • Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans, and annual or other periodic reports. • Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications. • Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead. • Participating as an active member on the global regulatory team and attending cross-functional meetings as required. • Conducting research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory strategy. • Assisting the global regulatory lead in authoring of regulatory strategy documents. • Collaborating and communicating regulatory strategy to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional areas. • Supporting maintenance (e.g., quality compliance and life cycle management) of oncology programs. • Support the global regulatory lead in label development. • Assisting with process improvement initiatives. • Performing regulatory administrative activities as needed. Requirements • Pharm D or Ph.D. or other related doctoral degree in biological science, chemistry, or related discipline with at least 2 years of relevant experience in the pharmaceutical industry. • Master's Degree with at least 4 years of relevant experience in the pharmaceutical industry. • Bachelor's Degree with at least 6 years of relevant experience in the pharmaceutical industry. • Excellent communication skills (both oral and written). • Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects. • Flexibility required. • Strong scientific and analytical skills with attention to detail. • Accountability • Adaptability • Biological Sciences • Chemical Biology • Clinical Risk Management • Complaint Management • Cross-Functional Teamwork • Data Quality Assurance • Drug Development • Economic Impact Analysis • Exercises Judgment • Innovation • Legislative Testimony • Machine Learning • Maintenance Management • Oncology • Periodic Reports • Pharmaceutical Management • Process Improvement Projects • Process Improvements • Quality Management • Regulatory Affairs Management • Regulatory Communications • Regulatory Compliance Nice-to-haves • Prior regulatory experience interacting with a major regulatory agency is highly preferred. • Experience in drug development, particularly oncology products, is highly preferred. Benefits • medical • dental • vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays • vacation • compassionate and sick days Apply To this Job Company : Merck & Co. Salary : Full-time
