Company DescriptionCoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people’s lives by connecting real-time data with world-class creative, content, and media in service of growth and Return on investment. CoLab is a “power of one” solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the atmosphere of a startup company with the stability and experience of a global leader.Job DescriptionThis is a hybrid role, 3x a week, based out of our NYC, Philadelphia, or Chicago office. The Senior Associate, Regulatory Promotional Operations will be responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical clients for promotional materials. This includes managing components of a submission package based on project type, experience working in Veeva and/or various other submission platforms, managing reference library uploads [includes collecting and validating according to agency or clients’ specifications], facilitating communication among team members about the status of active projects, training brand teams, and onboarding new team members on Submission process.
Support PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) review
Submit completed materials to the client, as determined by the clients’ specifications
Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines
Understand and document client mandated MLR submission requirements including maintaining a working knowledge of the client’s internal tools/systems for uploading and routing projects for review
Train others on use/process and ensure these protocols are maintained and shared out to the dept or the Agency on a regular basis
Prioritize work effectively to meet all client deadlines across your own assigned brands and for others in the dept
Comfort in onboarding new/existing staff and provide consistent guidance and feedback
Act as a point of contact for internal Account and Project Management teams to answer submission questions
Attend and contribute to internal/external team status meetings
Collaborate with internal, multidisciplinary team members (Account Services, Project Management, Design, User Experience, etc.)
Stay abreast of regulatory industry trends
Qualifications
Preferred 1-2 years of experience working on MLR submissions
Experience in Pharmaceutical Industry or Healthcare Marketing
Experience in Project Management a plus
Proficiency using Veeva submission software
Must be articulate with strong attention to detail and proficient reading comprehension
Excellent spelling, grammar, and prooing skills
Ability to successfully organize, prioritize and manage complex projects in a deadline-driven environment is necessary
Excellent critical thinking skills
Ability to follow strict procedures and meet deadlines
Initiative-taking and committed to completing assigned tasks
Comfort in providing feedback to others
Effective communication and people skills, a positive attitude and the ability to thrive in a collaborative agency environment with multi-disciplinary teams needed
Additional InformationAll your information will be kept confidential according to EEO guidelines.Compensation Range: $24.52- $36.06/hr. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. This role may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. This role may also qualify for participation in our 401(k) plan after eligibility criteria have been met. The Company anticipates the application deadline for this job posting will be 06/10/2024.