Senior Associate, Product Information/Claims Support

Senior role in the Medical Affairs department supporting product information, claims support, labeling, scientific accuracy and regulatory documentation for pharmaceutical products.

Responsibilities

Identify, plan and implement key projects to improve quality, reduce cost, increase productivity and improve cycle time; Develop and coordinate the performance excellence/performance improvement vision and deployment planning; Development and maintenance of Client Core Data Sheet (CCDS), Core Safety Information (CSI) and high-quality scientific proof; Perform compliance checks, and compilation and formatting of Dossiers; Review of source documents, GAP analysis and providing regulatory contribution; Prepare and review SOPs for writing Global Labelling documents; Provide therapeutic area knowledge support and clarification of science as needed; Conduct and evaluate literature searches and analyze scientific literature; Create standard language for product information reference manuals including FAQs for new product launches, media issues, and publications; Provide medical support in reviewing printed packaging components, labeling, and compendia; Collaborate with physicians as the medical representative on cross-functional teams (copy clearance committees) to ensure medical/scientific accuracy; Participate in creation of medical training materials and programs; Assist in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS; Support Investigator initiated studies including correspondence with investigators and facilitating review and approval of IIS proposals; Ensure assigned tasks are delivered on time or before deadlines; Ensure error-free and acceptable quality in assigned deliverables; Responsible for confidentiality, integrity, availability, and safeguarding of data; Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements

Requirements

Bachelor's degree in science or above and in alignment with project/business team requirements; Minimum of 3 to 5 years of relevant experience in identified functional domain/business workstream; Minimum 4-5 years in a pharmaceutical or consumer health care organization, chemical raw material manufacturer, or another FDA-regulated environment such as a medical device manufacturer; Background in labeling/artwork management, in the personal products; Must be detail-oriented to pick up inconsistencies or errors in material