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Commercial Regulatory Affairs Associate

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Company :
Eisai US

Location :
Woodcliff Lake, New Jersey

Expiry Date :
Sat, 19 Dec 2020 23:59:59 GMT

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Description :
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world’s most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary This position is responsible for coordinating the review and approval process for the Copy Review Committee (CRC) and Product Medical Review Committee (PMRC) meetings. This involves managing the advertising/promotional materials and scientific exchange materials for review and approval, and ensuring the Material Owners and reviewers follow all applicable company policies and guidelines. The Commercial Regulatory Associate is responsible for properly documenting all steps of the process and working cross functionally with Legal, Medical, Commercial Regulatory, and Marketing when defining priorities and building appropriate timelines. The Commercial Regulatory Associate is required to act as a project manager responsible for moving each project through the process from initial review to final approval and submission to FDA as needed. This role ensures all materials are reviewed and approved according to the process outlined in the Standard Working Procedures. Once materials are approved, the Commercial Regulatory Associate is responsible for documenting all approvals and working closely with Global Regulatory Operations to ensure appropriate samples are sent to FDA, as appropriate. Essential Functions – Train organization and vendors on CRC Process and PMRC Process, including the review and approval of materials through electronic review system. 10% – Ensure adherence to CRC and PMRC SWP; Oversee and manage the review and approval process for CRC and PMRC materials. 20% – Collaborate with Material owners and Commercial Regulatory reviewer to set realistic agendas and ensure the timely distribution of agenda and materials; Review materials submitted for CRC and PMRC review to determine appropriateness and completeness prior to scheduling CRC and PMRC meeting. 10% – Support Material owner with facilitation of CRC and PMRC meetings and capture of reviewer comments. 10% – As needed, act as a liaison with vendors to ensure incorporation of CRC and PMRC comments. 10% – Assist Commercial Regulatory reviewer with review of resubmitted pieces and final flats and ensure all requested changes have been incorporated; Manage proof reading process of promotional items prior to release to printer and submission to FDA as needed. 20% – Prepare CRC approved materials for submission to FDA on Form 2253 at time of first use. 10% – Generate reports to evaluate a variety of metrics related to the review and approval of materials through CRC and PMRC. Provide Material owners with expiration reports to ensure all materials are scheduled for a timely annual review prior to expiration and retirement from use. 10% Requirements – Bachelor’s Degree with pharmaceutical industry work experience (2-3 years) preferred – Excellent written and oral communication skills including ability to train and present effectively – Attention to detail (including proof reading skills) – Process orientation and management is critical – Excellent project management skills including meeting facilitation, organization and time management – Experience in vendor management – Documentation and recordkeeping skills – Microsoft Office, including Excel, Word and PowerPoint Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Please Click On The Following Link For More Information Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Right To Work E-Verify Participation