Responsibilities | Primary 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.
- Perform compliancee 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
- 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.
- Conduct and evaluate literature searches and analyze scientific literature.
- Create standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.
- Provide medical support in reviewing the printed packaging components, labeling, and compendia.
- 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.
- Participate in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.
- 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.
- 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.
- Contribute to research activities via scientific publications
- Attend key medical/pharmacy professional meetings to gain knowledge related to therapeutic areas in relevant markets
- Research educational and technical materials in support of local and regional speakers upon solicited request
- Assist in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.
- Support Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals
Secondary Responsibilities: - 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 compliancee
- 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 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
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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
- 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.
- Background in labeling / artwork management, in the personal products Must be detail-oriented to pick up inconsistencies or errors in material
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