Regulatory Writer-MERCK- USA - PA - Upper Gwynedd
Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Under the direction of the Manager/Associate Director, Worldwide Product Labeling, the Regulatory Writer is responsible for the drafting of labels for new products for presentation to the Label Evaluation and Development Team (LEAD) and the Label Approval Strategy Team (LAST) and for revision and updating of product labeling for marketed products worldwide. Collects and reviews information pertinent to the safety and efficacy of marketed products. Prepares and circulates revised labeling for approval throughout the Company. Presents proposed labeling revisions to LEAD and LAST. Reviews periodic reports and Adverse Drug Reaction Reports and prepares labeling summaries for these reports. Prepares annotated files of labeling for the Company