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…