Senior Associate, Medical Affairs

About this role

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.

• Performing compliance 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

• 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.

• Conducts and evaluates literature searches and analyze scientific literature.

• Creates standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.

• Provides medical support in reviewing the printed packaging components, labeling, and compendia.

• 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.

• Participates in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.

• 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.

• 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.

• Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.

• Supports Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals

• Performs quality review of the Epidemiology authored sections of the RMP and provides feedback on quality assessment finding.

This role also involves:

• 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 compliance

• 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 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

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