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Jobs/Senior Associate, Medical Affairs

Senior Associate, Medical Affairs

clinchoice

Pasig City, Philippines Posted yesterday
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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

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