Who we are looking for: 

The Regulatory Submission coordinator is responsible for collaborating with the internal client team in the preparation and delivery of materials for submission to our Pharmaceutical clients for Medical/Legal/Regulatory (MLR) review. This includes creating components of a submission package (both electronically and/or in hard copy as needed), managing references, including collecting and validating according to VML Health or client specifications, facilitating communication among team members about the status of projects and producing all final materials being delivered to the client, including making PDFs, researching and accessing materials for binders and ordering all materials associated with submission

What you’ll be doing:

• Submit completed materials to the client, both electronically and/or in hard copy, as determined by the clients’ specifications, including the “tagging and linking” process which electronically identifies and joins claims to their specific citations eg, journals, data on file documents, posters
• Responsible for referencing process for materials submitting into the systems
• Works closely with the Copywriter and/or Medical Editor to ensure the accuracy of the of the reference information within the client system Represent Wunderman and establish productive relationships with appropriate client MLR review board coordinators to assure that the Agency is following MLR submission best practices
• Coordinate, assemble and/or prepare for submission various pre and post approval materials to the FDA for consumer marketing materials review
• Responsible for working with manager to ensure tracking of submissions on a daily and weekly basis by Maintaining a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines
• Works with Manager to enforce strict preset procedures and regulations set forth by client MLR review teams and FDA guidelines
• May also be asked to attend and contribute to internal team status meetings
• Submits timesheet accurately and in a timely manner
• Adheres to the estimated time allocated for submissions task
• May also be asked to work with Project Management team to assist in ensuring estimates are entered into the financial system (JDE)

What You’ll Need: 

• Experience in Pharmaceutical Industry or Healthcare is preferred, but not required
• Comfortable learning and mastering multiple client submission platforms, or familiarity with similar technologies and digital platforms
• Must have Strong communication skills, be very detailed oriented and have strong problem- solving skills
• Ability to successfully organize, prioritize and manage complex projects in a deadline-driven environment
• Need to be a positive collaborator and team player
• Excellent spelling, grammar and proofreading skills
• Proficiency in Windows and Mac programs, web and mobile platforms, Microsoft Office Suite Adobe Acrobat
• Ability to follow strict procedures and meet deadlines
• Interest in Regulatory Affairs, Journalism or Pharmaceuticals field is useful, not required

VML Health is an equal opportunity employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability, or other protected group status. We believe in creating a dynamic work environment that values diversity and inclusion and strives to recruit a diverse slate of candidates to help us achieve that goal.