Associate, Global Submissions Mgt at Eisai in Woodcliff Lake, New Jersey

Job 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

The Associate, Global Submissions Management, is responsible for various day-to-day functions related to Global Regulatory Services Operations, including supporting global submission management regulatory activities and safety alert reporting activities. This role supports technology and operations at Eisai.

Essential Functions

GSM Submission Activities (50%)

Support Regulatory Maintenance Submission Activities, including the US Office of Prescription Drug Promotional material (OPDP) DDMAC submissions. (20%) Perform document submission readiness activities on various Global submission types, including formatting, building, compiling, validating, bookmarking, hyperlinking, and archiving using in-house publishing compilation software and validation tools and ensure the timely and accurate submission of regulatory documentation (20%) Performs QC activities on regulatory submission documents to ensure they are submission-ready and adhere to writing style guidelines. (10%)

Safety Reporting Activities (30%)

Perform all activities related to the distribution of Individual Case Safety Reports (ICSRs). (20%) Monitors and audits the company's product surveillance program including, the intake, evaluation, processing, and follow-up on adverse reports. (10%)

GRSO Activities (20%)

Identifies issues/provide resolutions and exercises judgment within well-defined procedures and practices to determine appropriate action Attend team meetings and participate in process improvement workstreams. Additional responsibilities as required to support Global Regulatory Service Operations. Participates in the contributions and development of best practices for GRSO processes. Analyze, monitor, and assess new and changing global regulatory regulations and compliance to understand their global impact on operations and technology platforms. Responsible for communicating, developing creative solutions and business processes to regulatory requirements, focusing on the end-to-end process completeness and accuracy.

Requirements

• Bachelor's degree preferred, or a minimum of 3 years of experience in Regulatory submission experience with a strong familiarity with the eCTD submission process.




• Strong communication and presentation skills (written and verbal)




• General knowledge and understanding of MS Word, Word templates (ISI Writer), Adobe Acrobat, ISI Toolbox, eCTD validation software, and standard Office tools




• General knowledge of regulatory procedures, filing requirements, and submission readiness is preferred




• Experience in processing OPDP submissions




• Good Knowledge of eCTD structure and eCTD Life Cycle Management operations




• General knowledge in FDA & ICH Guidance documents




• Must demonstrate flexibility and be able to adapt quickly to changing requirements and priorities




• A results-driven individual with strong problem-solving and critical thinking skills, and strong attention to detail




• Ability to manage small-scale projects to completion within and outside of the direct department.




• Technology: Familiarity with Veeva Vault (RIM) and Document Management Systems is preferred




• Experience working as a member of a team in a timeline-driven environment with limited supervision is required




• Ability to multi-task and work well under tight timelines




• Excellent leadership and interpersonal skills




• The ability to organize, analyze technical data and identify issues or gaps is preferred




• Knowledge in change management is preferred

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.

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