Senior Associate, Regulatory Promotional Operations

4 weeks ago


New York County New York, United States Publicis CoLab Full time
Job Description

This 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



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