Kelly Services Project Manager II in Cambridge, Massachusetts
Seeking a Project Manager II for a 3-6 month assignment in Cambridge, MA.
OBJECTIVE: Project Manager, Training, Standards and Regulatory Intelligence is responsible for supporting the day to day tasks for training compliance activities, regulatory intelligence activities and other miscellaneous administrative and project management tasks in support of the operational goals.
Principal responsibilities include but are not limited to: Track, monitor and maintain project lists; Schedule key stakeholder meetings; Capture minutes and action items. Follow up as needed; Support training requests as needed; Support Reg intelligence requests as needed; Work closely and partner with several Subject Matter Experts to plan regulatory safety strategies and tactics and facilitate engagement with stakeholders on key topics of interest. Ensures regular safety; RI updates to provide education, knowledge sharing, newsletters, reports and other modes of communication to advance safety regulatory expertise and decision making for the region; Research global regulations and guidance documents related to Pharmacovigilance. Send follow up communications on compliance metrics as needed; Partner and collaborate with other PMs to ensure audit findings and CAPA findings are being completed in a timely manner; Track AE and Product Complaints metrics to ensure global completion; Collaborate with CLIX coordinator to ensure compliance course requirements are defined and appropriately assigned. Represents Training and Regulatory Intelligence function internally and externally
ACCOUNTABILITIES: Provide PM support and leadership for training related issues and advise team of potential issues and solutions Prepare data, interpret and perform impact analysis regarding metrics for training compliance. Manage the investigation of non-compliance and implementation of corrective measures where required in the scope of training activities. Develop and distribute regular reports regarding training compliance activities to key stakeholders. Author and review quality documents supporting training processes. Perform impact analysis for PV compliance strategies and working practices. Support development of role based training matrices. Serve as the contact point for training needs, as needed. Collaborate with Compliance to ensure CAPA findings are being tracked and completed as scheduled. Liaise with QA Documentation and Training Department as required. Escalate issues/problems to management as needed. Perform other tasks assigned by manager to assist in departmental activities.
REQUIREMENTS: BS, RPH, RN HCP, or Life Science required; Post-graduate degree or equivalent preferred In depth knowledge and comprehension of the Pharmaceutical industry, Pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions. Understands and interprets complex scientific issues across projects and therapy area s of responsibility as it relates to pharmacovigilance regulatory requirements, regulatory intelligence, and strategy for the region. Excellent knowledge of instructional design in regulated training content and curriculum. Works strategically to realise organizational goals. Critical thinking and decision-making skills.
For immediate consideration please call 732-246-0215 or email to email@example.com