Regulatory Review Manager job Parsippany-Troy Hills New Jersey
Regulatory Review Manager job Parsippany-Troy Hills New Jersey
My Spider Scam Awareness Contacting Us F. A. Q.
 
Job Seekers
Search Jobs
Browse Jobs
Post a Resume
Job Alerts
 
Employers
Search Resumes
Browse Resumes
Post a Job

Regulatory Review Manager Job



Employer Name: SpiderID: 8357454
Location: Parsippany-Troy Hills, New Jersey Date Posted: 1/22/2019
Wage: Negotiable Category: Advertising
Job Code: CCG1-18-03

Job Description:

Ogilvy Health, is committed to pervasive creativity and measurable effectiveness in healthcare communications, across every marketing platform. The agency's main offices are in New Jersey and New York, with additional hubs in markets critical to clients' global aspirations. The organization houses and maintains individual Ogilvy CommonHealth and Ogilvy Healthworld brand identities within the marketplace.



Description:


The REGULATORY REVIEW MANAGER (RRM) is responsible for the project management of client Medical, Legal, and Regulatory (MLR) submission deliverables. Strong attention to detail and a passion for understanding finite requirements associated with client(s) MLR review and approval process is a must. The RRM will manage the MLR submission requirements for each project from kick-off to post mortem, working with Project Management and Account Management to clarify program design and details.

Responsibilities:



  • Works with multi-functional team to develop sound implementation plans for all MLR submissions required to ensure MLR approval of materials the agency develops on behalf of the client

  • Maintains Submission Plans for all assigned client programs and sub-tactic executions (Table of Contents, Timeline, and responsibility matrix)

  • Manages/trains team of Submission Coordinators (TBD)

  • Conducts agency submission kick-off (as required), submission core team, and weekly submission status meetings

  • Responsible for the assembly, coordinating, delivery, and submission of regulatory documents to client MLR system(s)

  • Provides requested submission documents to agency program leads for client approval prior to system submissions

  • Provides concise and appropriate feedback on project MLR submission inputs, outputs, internal processes, and quality assurance measures to the appropriate functional groups

  • Facilitates resolution of timeline issues as related to the submission of any agency deliverable to client MLR review committee

  • Provides guidance on good documentation and submission best practices

  • Coordinates submission documents (responsible for uploading documents, and create and manage review workflows for required finalization and approvals)

  • Maintains and tracks regulatory commitments

  • Streamline and enhance the agency MLR submission development process for multi-functional team

  • Ensures all QA has been performed and approves completeness of project MLR submission deliverables

  • Ensures that project submission resource allocations are accurate and in line with project estimated budgets and scope

  • Develops submissions plans and integrates tasks, milestones and resources with overall program timeline and budget as overseen by project management lead

  • Manages the submissions issue logging and management process over the life of an engagement

  • Provides ongoing feedback and involvement in ongoing submissions department operational improvement activities


Requirements:



  • BS / BA Degree (preferred)

  • Minimum requirements include 3-5 years professional work experience.

  • Proven experience working with a formal client regulatory review process

  • Desire to learn and understand the Pharmaceutical Regulatory environment

  • Project management skills desired. Ability to learn and apply project management professional best practices.

  • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

  • Required Soft Skills: Can work independently (some guidance from direct manager anticipated), ability to multi-task, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

  • Required Technical Skills:

    • Solid PC skills using Microsoft software and Adobe Acrobat.

    • Previous exposure to electronic document management systems (EDMS) is desirable.

    • Additional software experience is valuable in Microsoft Project, Microsoft Visio and Email packages.




We are an Equal Opportunity Employer



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: James Tahiri Company Type:
Company: WPP-Ogilvy CommonHealth Worldwide
City:
State:
Zip:

Send ad to a friend


    





© 2020 Job Spider
Privacy Policy | CC Marketing Sites | Site Map | Links