Senior Associate, Medical Affairs

About this role

<p><strong>Responsibilities:</strong></p> <ul> <li>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.</li> <li>Responsible for targeting completion of process improvement projects within a specified time frame while achieving a cost reduction goal.</li> <li>Develop and co-ordinate the performance excellence / performance improvement vision and deployment planning as defined by the Executive Team.</li> <li>Achieve buy-in from all decision makers for the successful application of performance excellence / performance improvement. Create team processes for optimizing results.</li> <li>Actively lead projects and provide individual contributions after key projects have been identified.</li> <li>Liaison with finance and other members of the organization in assessing, tracking and reporting the financial benefit of a Performance Excellence project.</li> <li>Provide management with project status updates, feedback, and appropriate reporting on key responsibilities and objectives.</li> <li>Development and Maintenance of Client Core Data Sheet CCDS, Core Safety Information (CSI) and high-quality scientific proof.</li> <li>Performing compliance checks, and Compilation and formatting of Dossiers</li> <li>Review of source documents, GAP Analysis and providing regulatory contribution <br>Prepare and Review SOP’s for writing Global Labelling documents  </li> <li>Provides 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.</li> <li>Conducts and evaluates literature searches and analyze scientific literature.</li> <li>Creates standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.</li> <li>Provides medical support in reviewing the printed packaging components, labeling, and compendia.</li> <li>Collaborates 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.</li> <li>Participates in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.</li> <li>Trains employees who require in-depth scientific/medical knowledge of relevant products/therapeutic areas and in support of local and regional speakers upon solicited request.</li> <li>Creates 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.</li> <li>Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.</li> <li>Supports Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals</li> <li>Performs quality review of the Epidemiology authored sections of the RMP and provides feedback on quality assessment finding.</li> </ul> <p><strong>This role also involves: </strong></p> <ul> <li>Effectively organize work to complete the assigned tasks to meet deadlines</li> <li>Ensure the assigned tasks are delivered 100% on time or before  </li> <li>Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work</li> <li>Support in review of work done by peer teammates, on need basis. </li> <li>Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule</li> <li>Ensure error free and acceptable quality in assigned deliverables</li> <li>Responsible to ensure training compliancee and timesheet compliance</li> <li>Ensure that all assigned goals [e.g. utilization, quality and timeliness] are met as per set standards for the performance year</li> <li>Follow and comply with the Company’s Code of Conduct, Policies, and Procedures,</li> <li>Responsible for confidentiality, integrity, availability, and safeguarding of data,</li> <li>Responsible for reporting of security incidents and PIMS breaches as applicable,</li> <li>Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements,</li> <li>Demonstrate adherence and compliance 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 </li> </ul> <p><strong>Skills and Qualifications:</strong></p> <ul> <li>Bachelor’s degree in science or above and in alignment with project / business team requirements</li> <li>Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream </li> </ul>