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Senior Associate, Regulatory Review

Location: New York
Posted on: June 12, 2021

Job Description:

Job Description

The Senior Associate, Regulatory Review is responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical and medical/surgical device clients for promotional materials. This includes knowing and creating components of a submission package based on medium, agility in working in VEEVA and/or various other submission platforms, managing reference library that includes collecting and validating according to SSW or clients' specifications, facilitating communication among team members about the status of projects currently underway, training brand teams, and data entry. Maintaining communication and cooperation on projects and processes across Saatchi & Saatchi Wellness (SSW) teams regarding all types of submission preparation and delivery: print, digital, video, and social media is vital. In addition, identifying ways to improve on process and efficiencies, as well as a high level of organization and attention to detail are required to ensure submissions are correct and error-free.

Core Duties and Responsibilities

  • Submit completed materials to the client, both electronically and/or in hard copy, as determined by the clients' specifications

  • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines

  • Understand and document client-mandated submission requirements and ensure these protocols are maintained

  • Experience with Veeva or other submissions platform

  • Comfort in onboarding new/existing staff to client processes

  • Proofread against multiple source documents to check for accuracy prior to submissions

  • Prioritize work effectively to meet all client deadlines

  • Act as a point of contact for internal Account teams and Project Management

  • Attend and contribute to internal/external team status meetings

  • Collaborate with internal, multidisciplinary team members (Account Services, Project Management, Design, User Experience, etc.)

  • Stay abreast of regulatory industry trends

Keywords: PUBLICIS GROUPE SA, New York , Senior Associate, Regulatory Review, Other , New York, New York

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