Senior Associate, Medical Affairs

ClinChoice

Philippines

3-5 Years

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Posted 17 hours ago
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Job Description

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