| Hiring Now : :Senior PM w Pharma PDM Experience : Location : : REMOTE at Remote, Remote, USA |
| Email: [email protected] |
| From: Subhra Mallick, Adventa Tech [email protected] Reply to: [email protected] Title : Senior PM w/ Pharma PDM Experience Location : REMOTE reporting to Andover, MA 01810 Duration : 6+ Months Visa : CITIZEN,GC EAD,GREEN CARD,H4 EAD,OPT EAD Moi : video MUST HAVE prior, "recent" Pfizer experience and PDM Sr Project Manager with Pharma PDM Experience Our client in Andover, MA, a leader in drug discovery and development is seeking a Sr Project Manager with Pharmacokinetics, Dynamics and Metabolism (PDM) experience to join a team working on regulated documentation harmonization and integration. This role requires experience with SOPs associated with GLP and GCLP Documentation as well as knowledge of control document creation. Summary Assist the PDM Compliance Lead responsible for managing and delivering the harmonization and integration of documents acquired through acquisitions by applying document management and technical transfer business standards using appropriate document management systems and corporate training systems, perform QC of Standard Operating Procedures/Business Practices/Job Aids, assist with authoring/revising described documents to meet PDM quality standards. Knowledge of GLP/GCLP operations, regulatory requirements and familiarity of GDMS, Gnosis and administration of the clients Learning Academy are critical to support integration activities. This is a hybrid position which requires the ability to travel to the client site in either MA or CT. Flexible hours to accommodate Eastern (primary) or Western time zones. Responsibilities Collaborate with colleagues across PDM regulated groups, as needed to track and manage key deliverables Manually transition documents to target application including meta data for mapping of content Revise SOPs for consistency with template QC of content and confirmation in target application Assist SOP and Training Administrators with documentation approval workflow and training course creation Generation of best practices and job aids, including transition to target application with meta data for mapping of content Additional duties relevant to harmonization and integration may be requested Requirements Bachelors degree plus 6 years experience or Masters degree plus 4 years experience Ability to collaborate with PDM regulated colleagues from bioanalytical, systems and compliance groups in MA, CT and WA sites Expertise in document management systems, administration of training systems and project management Traits Self motivated with a high degree of initiative Ability to organize and work independently Good sense of judgment Ability to prioritize Ability to thrive in a fast-paced environment where multi-tasking and prioritization are required Ability to handle multiple initiatives, quickly-changing priorities, and customer expectations Excellent facilitator with strong leadership skills Results and process oriented Keywords: green card Connecticut Massachusetts Washington Hiring Now : :Senior PM w Pharma PDM Experience : Location : : REMOTE [email protected] |
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| Thu Nov 21 10:17:00 UTC 2024 |