Publicis Healthcare Communications Group - Philadelphia, PA3.7

ContractEstimated: $72,000 - $94,000 a year
RFH_Freelance_SeniorRegulatoryAssociate(Job Number: RHW000609)
Primary Location-United States-Pennsylvania-Philadelphia

Senior Associate, Regulatory Affairs
The Regulatory Affairs team at Razorfish Health is seeking an experienced, meticulously organized process champion in the form of a Senior Regulatory Affairs Associate. The right candidate should have some pharmaceutical regulatory or marketing experience and be familiar with MLR procedures. The Senior Associate is primarily responsible for interfacing with internal and external client teams to execute submissions of creative content to our pharmaceutical clients’ Medical-Legal-Regulatory (MLR) review committees. We manage and track all MLR submissions (print, digital, HCP, consumer-facing, etc.) for our diverse clientele. Over time, this candidate will learn about brand content and MLR guidelines to ensure consistency and compliance across projects and channels. A candidate must be adaptable, innovative, a willing leader, and able to thrive in an exacting, deadline-driven environment.

The Regulatory Affairs team serves our clients by ensuring quality creative, efficient processes, and timely approvals. Therefore, the Senior Regulatory Affairs Associate must use knowledge of industry regulations, client processes, and experience to optimize the delivery of compliant materials. They collaborate with client contacts, interagency disciplines, and members of their team to achieve common goals.
Responsibilities and Duties
Create and/or oversee the creation of MLR submissions, ensuring compliance with clients’ submission protocols and FDA/OPDP regulations for our clients
Establish timelines, scope deliverables, and assign submission tasks to team resources to ensure timely delivery of submission components to meet target MLR review dates and subsequent approval timelines
Serve as the primary point of contact between the agency and the clients’ MLR committee to confirm expectations and timing requirements are met, and to exchange information or answer questions that arise during the MLR review process
Demonstrate mastery of the intricacies of each client’s MLR process, including proficiency with the client’s internal tools/systems for uploading and routing projects for review
Review marketing materials to ensure that all content adheres to Regulatory guidelines and verify that all MLR feedback is accurately captured and implemented for consistency across the brand
Document client MLR process and requirements for each brand and develop guidelines and templates to facilitate efficient and compliant submissions
Conduct internal training and education sessions that contribute to employees’ adherence to the clients’ policies, processes, and standards for promotional material development and compliance
Ensure maintenance of MLR status dashboards and comprehensive submission archives and create standard operating procedures (SOPs) for team to follow
Expedite MLR approvals by anticipating MLR reviewer’s concerns, identifying delays and pitfalls, problem-solving, and developing contingency plans that satisfy client and MLR goals
Demonstrate ability to prioritize, organize, and support multiple projects across brand teams, client companies, and team needs in a deadline-driven environment
Exhibit willingness to go above and beyond the standard responsibilities, work hours, and written responsibilities to ensure client satisfaction and agency success
Attend MLR meetings as needed to support review and approval of promotional materials
Master industry-standard electronic routing tools such as Veeva Vault, Zinc Maps, and Aprimo
Stay apprised of client and regulatory guidelines and pharmaceutical industry news and trends
Bachelor’s degree in areas such as English, Journalism, Communications, a relevant science, or equivalent certification
2-4 years of experience in pharmaceuticals, healthcare marketing, or project management
Preferred experience in the preparation of complex deliverables in regulated or highly scrutinized fields (i.e., scientific, medical, journalistic, financial, or legal firms)
Advanced Adobe Acrobat and SnagIt capabilities
Extraordinary attention to detail
Excellent verbal and written communication skills
Comprehension of scientific content
Exceptional spelling, grammar, and proofreading skills, proficiency with AMA style
Excels under deadline, but always works to mitigate pressure situations by emphasizing the importance of planning, being flexible, and collaboration
Demands the highest quality of work
Can prioritize conflicting timelines
Maintains calm and work accuracy in fast-paced, high-pressure circumstances
Thrives in a team setting
Collaborates well with all levels of the organization
Self-motivated, curious, change agent, process champion
Accountable, disciplined, organized, problem solver
For immediate consideration, please email your resume (and portfolio, if applicable) to our Recruiter, Nicole Simpson at Nicole.simpson@razorfishhealth.com.