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We're looking for a R and D Quality Procedures Coordinator
, working in Pharmaceuticals and Medical Products
industry in 121 Seaport Boulevard, Boston, Massachusetts, 02210, United States
- Facilitates the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) Manages the change request, deviation and periodic review processes of procedural documents.
- Assists in the assessment and implementation of company Quality Standards in R&D.
- Assists in the implementation of external regulatory changes in the appropriate procedural documents.
- Assists R&D in effectively implementing and leveraging available Document Control tools (e.g. firstDoc, PleaseReview, DocuSign). This will need to be achieved through coordinating activities with the centralized Quality Systems support team
- Serves as a super user of the electronic tools and technologies supporting the R&D Quality System.
- Facilitates document generation process in the document management system and supports processes involving controlled documents.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- 8+ years of hands-on experience in pharmaceutical/biotech industry
- Experience working in R&D functions (Clinical, Regulatory, Pharmacovigilance, etc.)
- Experience in Procedural Document Lifecycle Management within a R&D Quality Management System including document workflow utilizing a Controlled Document Management System
- Experience working with geographically and culturally diverse teams
- Ability to influence peers without positional authority
- Strong facilitation, negotiating and presentation skills
- Able to work with all levels in the organization
- Able to work effectively across functional, divisional, site and Vendor (CRO) boundaries
- Able to work in ambiguous situations to identify and resolve complex problems
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?