My client, a global life sciences company based in Connecticut, has an exciting, ever evolving, and significant market that touches our lives. Through the delivery of insightful technologies and products to health care providers, they envision a world with healthier babies, individuals, and families.
This company is a market leader in the development, production, and marketing of medical devices and minimally invasive surgery used to advance women s healthcare. They are a company on the move and their employees are dedicated to keeping the momentum going. Their team cares enough to want to make a difference for the communities in which they live and work and in the well-being of women. They boast a culture of absolutely NO politics, strong collaboration, people that are approachable and willing to help!
My client is looking for a Promotional Advertising Review Committee Leader to join their team. This is a key, pivotal role for the company. The ideal candidate for this role is someone who has strong experience in marketing and materials promotional review within the pharmaceutical industry. You will OWN the function and ensure the process runs as intended and smoothly. This company has acquired 40 products in the past 20 years and will likely be acquiring 2 more pharma products this year. They have 600 products, 10 of which are actively promoted. Solid company.
Solid experience and understanding of the ins and outs of the promotional review process
Comfortable pushing back as needed, including with senior leadership
Someone that wants to run their own show and own the process
Desire & ability to roll up your sleeves & get your hands dirty
May work from home Mondays and Fridays
Must be authorized to work in the US without sponsorship
Lead the Promotional Advertising Review Committee (PARC) process and act as a liaison between the PARC, Marketing, Regulatory, Medical, and Legal, and other involved parties in order to facilitate rapid and accurate review of all the company s pharmaceutical and medical device advertising and promotional materials
Supervise the approvals (per SOP) of all promotional material projects submitted for review using Veeva and other software programs/platforms
Notify PRC reviewers of new submissions and monitor the review status of each submission to ensure timely reviews
Provide feedback to various members of the marketing team to ensure correct submission and completion of projects.
Utilize various software programs to create reports used to monitor the number of pending projects currently in the PRC system, monitor the efficiency of the process and monitor the completion of projects by marketing sponsors
Organize, prepare, and maintain the required archives (hard copy and electronic) for each submission
Prepare a comprehensive Claims and Approved Materials Binder for key promoted products from the Claims documents and approved promotional materials that pass through the PARC process
Ensure all files have been completed and properly stored in a timely manner
Review proposed final copies of submissions to ensure that all mandatory comments have been properly addressed
Provide recommendations and guidance to sponsors when all mandatory changes have not been properly addressed
Responsible for ensuring appropriate copies of final submissions that include FDA-regulated products are delivered to Regulatory Affairs for submission to FDA.
Coordinate with the Marketing Communications Coordinator to ensure that our fulfillment centers have accurate information for the dissemination of approved materials to the field.
Manage the PARC Fulfillment Center SOP processes for release of approved materials
Identify, analyze, and solve problems using inventive and creative solutions that benefit the PARC process and the entire organization. Coordinate with MarCom Leader regarding these observations and recommendations
Create and update PRC process training materials
Develop and improve training presentations and design tools to improve the accuracy and efficiency of submitted projects
Lead and conduct training that certifies that all sponsors are knowledgeable regarding the PRC process and pertinent software
Provide refresher training for sponsors regarding areas of improvement
Literature Quality Assurance SOP and FAQ documents
Background in Pharmaceutical Promotional review; experience with Medical Device review a plus
Works within an environment where balancing conflicting priorities is essential
Often has to mediate between marketing and Legal/Regulatory/ Medical to balance opinions and drive to the strongest work product
Acts as a liaison between marketing, PARC members, Regulatory, Legal, and various other entities
Partners with Promotional Material Storage Facility
Ideally would have knowledge of company products, competitor products, and knowledge of the pertinent regulatory agencies
PARC process serves an important function of balancing the approval of high-quality promotional materials while managing risk to the company
Leader in this role will make a significant positive impact on the company
Will have the authority and senior leadership backing to effectively drive the PARC process
Strong, interpersonal, written, and verbal communication skills
Outstanding organizational, analytical, and judgment skills
Proficient computer skills with emphasis on Veeva, databases, and Excel