Senior Associate, Regulatory Review

  • 375 Hudson St, New York, NY 10014, USA
  • Full-time

Company Description

Walk the halls of SSW and you'll find a rather spirited and passionate group of people. It's a stimulating assembly of professionals—writers, managers, strategists, art directors, planners, analysts and developers.  

We believe the only way to move people to live healthier, happier lives is to create ideas that move them emotionally. Never powered by reason alone, people – whether they’re consumers, caregivers, doctors or payers – are motivated to take action by emotion. Only when people feel something will they be willing to do something.  

For decades, Saatchi & Saatchi Wellness has provided consumer and professional marketing, strategic consulting and medical education to pharmaceutical and wellness brands. Today, we're dedicated to continuing that legacy by raising the bar and crafting award- winning work online, on-air, in print and in-office. Going beyond addressing simply the absence of illness, our vision is to inspire a healthier, happier world. Together, we strive to help brands thrive in today’s culture of wellbeing by leveraging the power of Wellness IntelligenceSM. 

Job Description

Saatchi & Saatchi Wellness is looking for a Senior Manager, Regulatory Review to join our team in New York.

About the Role:

  • Participates in meetings and strategic discussions with clients and teams
  • Communicates frequently with internal client teams in a professional manner
  • Work with the team to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review.
  • Establish procedures for internal teams and advise on specific projects to aid smooth and fast review by clients.

Client & Account Services/ Communication Skills

  • Work with new internal client teams to establish appropriate procedures to meet the external client's regulatory review procedures and meet agency quality standards
  • Advise internal client teams on submission strategy and requirements to minimize review period and ensure external client(s) satisfaction
  • Clear communication and attention to detail are essential.

Material Preparation/Submission

  • Prepare completed edited content to Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations)
  • Create and/or oversee the creation of the components for submission and ensure they conform to client and agency guidelines
  • Create, update, and disseminate procedure(s) specific to the clients supported, and work with teams to ensure comprehension and follow through

Project/Production Management

  • Submit materials to the client (both electronically and/or in hard copy as determined by the clients' specifications), and track the progress of each project through the various stages of MLR review
  • Determine the time and effort required to complete each submission, and work with the Project Management team to integrate into the project timelines to ensure sufficient time for submission
  • Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
  • Serve as primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
  • Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines

Qualifications

  • 4-6 years of experience in the preparation of complex deliverables under tight deadline constraints is required
  • Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required
  • Experience communicating with clients directly is required
  • Demonstrated knowledge of FDA pharmaceutical regulations through appropriate training or previous experience is required
  • At least one-year experience in Pharmaceutical Industry, Advertising Agency, or Healthcare is required
  • Bachelor's degree

Additional Information

All your information will be kept confidential according to EEO guidelines.

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