Senior Associate, Product Information/Claims Support

JOB DESCRIPTION Job Title Senior Associate, Product Information/Claims Support (MA) Department Medical Affairs/Medical Affairs Responsibilities Primary Responsibilities: · Identify, plan and implement key projects to improve quality, reduce cost, increase productivity and improve cycle time resulting in significant business improvement and customer satisfaction. · Responsible for targeting completion of process improvement projects within a specified time frame while achieving a cost reduction goal. · Develop and co-ordinate the performance excellence / performance improvement vision and deployment planning as defined by the Executive Team. · Achieve buy-in from all decision makers for the successful application of performance excellence / performance improvement. Create team processes for optimizing results. · Actively lead projects and provide individual contributions after key projects have been identified. · Liaison with finance and other members of the organization in assessing, tracking and reporting the financial benefit of a Performance Excellence project. · Provide management with project status updates, feedback, and appropriate reporting on key responsibilities and objectives. · Development and Maintenance of Client Core Data Sheet CCDS, Core Safety Information (CSI) and high-quality scientific proof. · Perform compliancee checks, and Compilation and formatting of Dossiers · Review of source documents, GAP Analysis and providing regulatory contribution Prepare and Review SOP’s for writing Global Labelling documents · Provide therapeutic area (e.g. Pain, Digestive Health, Smoking Cessation or UR/Allergy) knowledge support and clarification of science as needed and contributes to research activities via scientific publications. · 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 the printed packaging components, labeling, and compendia. · Collaborate with physicians as the medical representative on cross functional teams (copy clearance committees) to both marketed products and support to new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy. · Participate in creation of medical training materials and programs that are used to support initial and ongoing training for new employees. · Train employees who require in-depth scientific/medical knowledge of relevant products/therapeutic areas and in support of local and regional speakers upon solicited request. · Create and develops strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls, or new or highly publicized medical discoveries or information. · Contribute to research activities via scientific publications · Attend key medical/pharmacy professional meetings to gain knowledge related to therapeutic areas in relevant markets · Research educational and technical materials in support of local and regional speakers upon solicited request · Assist in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS. · Support Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals Secondary Responsibilities: · Effectively organize work to complete the assigned tasks to meet deadlines · Ensure the assigned tasks are delivered 100% on time or before · Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work · Support in review of work done by peer teammates, on need basis. · Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule · Ensure error free and acceptable quality in assigned deliverables · Responsible to ensure training compliancee and timesheet compliancee · Ensure that all assigned goals [e.g. utilization, quality and timeliness] are met as per set standards for the performance year · Follow and comply with the Company’s Code of Conduct, Policies, and Procedures, · Responsible for confidentiality, integrity, availability, and safeguarding of data, · Responsible for reporting of security incidents and PIMS breaches as applicable, · Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements, · Demonstrate adherence and compliancee to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner Skills and Qualifications · 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