Senior Associate - Product Information/Claims Support

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