PSG Global Solutions Careers
R and D Quality Procedures Coordinator
PSG Global Solutions Careers, Boston, Massachusetts, us, 02298
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R and D Quality Procedures Coordinator , working in
Pharmaceuticals and Medical Products
industry in
121 Seaport Boulevard, Boston, Massachusetts, 02210, United States .
Facilitate the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) Manage the change request, deviation and periodic review processes of procedural documents.Assist in the assessment and implementation of Quality Standards in R&DAssist in the implementation of external regulatory changes in the appropriate procedural documents.Assist 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.
Our Client
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 industryExperience 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 SystemExperience working with geographically and culturally diverse teamsAbility to influence peers without positional authorityStrong facilitation, negotiating and presentation skills. Able to work with all levels in the organizationAble to work effectively across functional, divisional, site and Vendor (CRO) boundaries.Able to work in ambiguous situations to identify and resolve complex problemsDemonstrated ability to be a trusted partner across Lines and through tiers of the organization.Contributes to a learning environment by sharing knowledge and best practices within and across the organizationProactively manages change by identifying opportunities and coaching self and others through the changes
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?
R and D Quality Procedures Coordinator , working in
Pharmaceuticals and Medical Products
industry in
121 Seaport Boulevard, Boston, Massachusetts, 02210, United States .
Facilitate the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) Manage the change request, deviation and periodic review processes of procedural documents.Assist in the assessment and implementation of Quality Standards in R&DAssist in the implementation of external regulatory changes in the appropriate procedural documents.Assist 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.
Our Client
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 industryExperience 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 SystemExperience working with geographically and culturally diverse teamsAbility to influence peers without positional authorityStrong facilitation, negotiating and presentation skills. Able to work with all levels in the organizationAble to work effectively across functional, divisional, site and Vendor (CRO) boundaries.Able to work in ambiguous situations to identify and resolve complex problemsDemonstrated ability to be a trusted partner across Lines and through tiers of the organization.Contributes to a learning environment by sharing knowledge and best practices within and across the organizationProactively manages change by identifying opportunities and coaching self and others through the changes
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?