HI Hope you are doing great today
Title: REMS Manager Location: REMOTE Duration: long term contract - candidates preference Interview: Phone/Skype *SUMMARY OF POSITION: * The Manager, Risk Evaluation and Mitigation Strategy (REMS) is responsible for directing and managing the REMS Department including developing product safety activities as well as any additional Risk Management activities. The Manager will collaborate in the planning, implementation and execution of activities related to the REMS Programs for product specific and/or class-wide REMS requirements. Once a REMS Program is operational, this individual will oversee the operations, acting as a liaison with outsourced vendors handling REMS activities. This individual provides internal direction, leadership and accountability for the company’s REMS programs and day-to-day management of the key risk management vendors as applicable. The Manager will play a pivotal role in managing timelines and deliverables for key risk management milestones for the company. This individual can effectively apply project management related support to meet overall corporate objectives in building a compliant REMS program. *ESSENTIAL FUNCTIONS:* - Serve as a representative who collaborates with colleagues towards a shared, single system REMS Program. - Provide vendor management – including managing of requests for proposals from initial request through coordinating and clarifying responses, develop and manage contracts, invoice reviews and approvals, evaluation and selection and deliverable reviews. - Responsible for the development of REMS strategy for new products (i.e., drugs in development) - Oversee and execute operational aspects of REMS activities as well as assigned special projects. - Prepare budgets/forecasts and track financials. Responsible for setting and managing overall project timelines and budgets for assigned projects. - Develop and implement key metrics to measure and report on progress of all initiatives. - Collaborate with Regulatory Affairs to compile REMS submissions and reports to the Food and Drug Administration (FDA). - Serve as a consultant to business development & licensing, marketing, and research & development to conduct product risk assessment. - Prepare risk assessment profiles for Product Development Team (PDT) and Safety review. - Monitor external environment for regulatory changes impacting risk management. - Chair Risk Management Core Team; facilitates topics and meetings for business review, approvals, discussion, etc. - Development and maintenance of department Standard Operating Procedures (SOPs) and working practices to support compliant infrastructure. Regards *Himanshu* 978-558-4666 x 104 *himan...@teknavigators.com* <himan...@teknavigators.com> *TekNavigators LLC* *100 Cummings Center, Suite 207 P, Beverly, MA 01915* *www.*teknavigators.com DISCLAIMER: This message and any attachments are solely for the use of the individual or entity to which it is addressed and may contain information that is privileged or confidential. If you are not the intended recipient, any disclosure, use or distribution of the information contained herein is prohibited. If you have received this communication in error, please notify the sender by reply e-mail and immediately delete this message and any attachments. You may reply and send an email with "Not Interested" in the subject line in order to discontinue communication. -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" group. To unsubscribe from this group and stop receiving emails from it, send an email to citrix-and-sap-problems+unsubscr...@googlegroups.com. To post to this group, send email to citrix-and-sap-problems@googlegroups.com. Visit this group at https://groups.google.com/group/citrix-and-sap-problems. For more options, visit https://groups.google.com/d/optout.
