Coordinator Medical Legal and Regulatory (MLR)

Overview

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

The MLR coordinator is the point person responsible for managing all of the internal Syneos MLR process for a dedicated client program. To ensure that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations. This position is responsible for ensuring that MLR timelines are met and the broader Syneos client team submits quality work that is fully compliant with all MLR SOPs. 

Responsibilities

• Develop a tracking process to ensure that the latest version of materials provided to the
  Committee for assessment is available, and that the appropriate version, approved by the MLR
  Committee is provided to the relevant parties for use and/or dissemination.
• Coordinate the scheduling of MLR meetings, whether in-person or telephonic
• Facilitate regular live meetings with the Review Committee, electronically capture all recommended revisions during meetings or independent of meetings when appropriate
• Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize
  and file approved minutes
• Follow-up to obtain required approvals, signatures and comments
• Liaise with and guide marketing agencies, project managers, operations managers on the
  standards of submission to the committee
• Cascade and enforce any new policies and guidelines related to review of materials
• Conduct quality checks of materials submitted for Committee review for completeness; proof
  final versions of approved materials for accuracy and completeness relative to Committee
  requested modifications
• Develop and maintain tracking sheets for all materials submitted for review by the Committee
• Prepare and circulate Committee meeting agendas, typically at least one week before the scheduled meeting
• Proactively communicate any delay or risk associated with inter-deliverables
• Lead internal forecast meetings, and develop short and long term review needs and schedules
• Assist in SOP deployment and enforcement
• Act as a system administrator by: Adding / Deactivating Users; Managing workflows by cancelling or modifying tasks; Uploading documentation; Removing expired documentations

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

• Bachelors Degree
• Fluent in English.  Additional languages an advantage
• Strong understanding of cloud-based systems like Veeva and Zinc MAPS, product information, industry terminology, key promotional regulations, compliance, and SOPs
• Ability to build and maintain strong relationships with cross-functional teams
• Effective working virtually
• Proficent in Microsoft Word, Excel and Powerpoint
• Project Management Accountability
• Collaboration
• Communication
• Knowledgeable of Industry Practices and MLR SOPs

 #LI-JJ1

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.