Senior Associate, Product Information/Claims Support

<p><strong>JOB DESCRIPTION </strong></p> <p><strong>&nbsp;</strong></p> <table width="708"> <tbody> <tr> <td width="150"><br> <p><strong>Job Title</strong></p> </td> <td width="558"> <p><strong>Senior Associate, Product Information/Claims Support (MA)</strong></p> </td> </tr> <tr> <td width="150"> <p><strong>Department</strong></p> </td> <td width="558"> <p><strong>Medical Affairs/Medical Affairs</strong></p> </td> </tr> <tr> <td width="150"> <p><strong>Responsibilities</strong></p> <p><strong>&nbsp;</strong></p> </td> <td width="558"> <p><strong>Primary Responsibilities:</strong></p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsible for targeting completion of process improvement projects within a specified time frame while achieving a cost reduction goal.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Develop and co-ordinate the performance excellence / performance improvement vision and deployment planning as defined by the Executive Team.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Achieve buy-in from all decision makers for the successful application of performance excellence / performance improvement. Create team processes for optimizing results.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Actively lead projects and provide individual contributions after key projects have been identified.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Liaison with finance and other members of the organization in assessing, tracking and reporting the financial benefit of a Performance Excellence project.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Provide management with project status updates, feedback, and appropriate reporting on key responsibilities and objectives.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Development and Maintenance of Client Core Data Sheet CCDS, Core Safety Information (CSI) and high-quality scientific proof.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Perform compliancee checks, and Compilation and formatting of Dossiers</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Review of source documents, GAP Analysis and providing regulatory contribution Prepare and Review SOP’s for writing Global Labelling documents</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Conduct and evaluate literature searches and analyze scientific literature.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Create standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Provide medical support in reviewing the printed packaging components, labeling, and compendia.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Participate in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Contribute to research activities via scientific publications</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Attend key medical/pharmacy professional meetings to gain knowledge related to therapeutic areas in relevant markets</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Research educational and technical materials in support of local and regional speakers upon solicited request</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals</p> <p><strong>&nbsp;</strong></p> <p><strong>Secondary Responsibilities:</strong></p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Effectively organize work to complete the assigned tasks to meet deadlines</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure the assigned tasks are delivered 100% on time or before</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Demonstrate Quality of Work &amp; Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support in review of work done by peer teammates, on need basis.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure error free and acceptable quality in assigned deliverables</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsible to ensure training compliancee and timesheet compliancee</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure that all assigned goals [e.g. utilization, quality and timeliness] are met as per set standards for the performance year</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Follow and comply with the Company’s Code of Conduct, Policies, and Procedures,</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsible for confidentiality, integrity, availability, and safeguarding of data,</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsible for reporting of security incidents and PIMS breaches as applicable,</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements,</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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</p> </td> </tr> <tr> <td width="150"> <p><strong>Skills and Qualifications</strong></p> </td> <td width="558"> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Bachelor’s degree in science or above and in alignment with project /</p> <p>business team requirements</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Background in labeling / artwork management, in the personal products Must be detail-oriented to pick up inconsistencies or errors in material</p> </td> </tr> </tbody> </table>