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Description: This is an updates
The Senior Associate, PV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents. The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations. The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Pharmaceutical (Pharmaceutical) organizations and sectors as appropriate by actively interacting with Pharmaceutical colleagues. The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives. The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables.
The position requires the ability to:
Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance.
Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external parties
Lead committee meetings and projects/initiatives professionally
Foster consensus and make decisions independently appropriate to subject matter and responsibilities
Interface regularly with Training and Document Control management to discuss status of projects and issues related to the development of controlled documents and for additional work assignments.
Interface regularly with GMO and OCMS staff members involved with the development, review, approval or training of assigned controlled documents.
Interface with other Pharmaceutical organizations as necessary.
Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met. 65%
Support procedural document initiatives and projects of moderate complexity. 15%
Facilitates Cross-pharma Reviews and Impact Assessments as needed. 5
Provide Audits and Inspections support and litigation request support. 5
Facilitate Procedural Document Committee meetings. 5
Other duties as assigned. 5
Manages release and control of updates to instructions, IIIifications, drawings and other documents. Controls distribution of new releases and recall-destruction of obsolete documents. Support the records management project objectives. Prepare periodic status reports. Accurately sort, file, mail and copy critical-vital records. Accurately input data in a database spreadsheet and provide reports as requested. Answers telephone, conveys message, communicate to corporate RDCF via phone and e-mail. Copies documents, using office-duplicating equipment. 4 years experience
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