Associate Project Manager, Regulatory Affairs
- Project Management
About this role:
The Associate Project Manager, Regulatory Affairs, position is an introductory role in the MRM//McCANN Regulatory Affairs capability. Regulatory Affairs is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) groups.
This position will support the Princeton pharmaceutical/health Client base. The Associate Manager will work to achieve expert level status on Client regulatory submission, collaboration and archive platforms/tools. This includes a supporting role in adhering to, maintaining processes and requirements for the capability.
- The Associate Project Manager, Regulatory Affairs will initiate the submission process
- Will provide support in tracking with the project from kickoff through to final submission Client MLR approval
- Responsible for organizing submission materials in accordance with the Client dictated requirements
- Will provide support in reviewing submission materials to ensure proper annotation, markups/redlining, screenshots and referencing in accordance with Client MLR requirements
- Responsible for submitting via Client MLR submission platform/tool
- Responsible for providing status updates on submission progresses
- Responsible for prepping and sending final samples, and 2253 materials when needed.
- Record keeping and knowledge base:
- Document and maintain project tracker and work with PM/Account teams to keep accurate records of submissions and due dates.
- Document and maintain current Client requirements for Client MLR submission
- Assigned Regulatory Affairs resource/s will maintain an intimate knowledge of the Client MLR schedule/s and will be resource of that information for the internal agency team
- Utilize and maintain regulatory document control and appropriate distribution of regulatory documents
- 1-3 years of experience in a relatable role preferred
- Must have strong interpersonal and problem-solving skills; be able to build strong relationships within the agency and client organizations, and must be able to participate in client and internal agency meetings with senior personnel
- Must be able to work effectively with partners and/or suppliers to deliver an overall solution to the client
- Must be able to manage multiple projects as one cohesive program
- Project management experience is an added plus
- Capacity for task and delivery management
- Capacity for risk identification and management
- Strong sense of ownership of process and results
- Waterfall/Agile experience is an added plus
- Strong writing and verbal skills
- Highly organized and detail oriented with an ability to influence others in these areas
- Ability to find creative solutions to complex problems and multi-task
- Must be comfortable working in an environment that utilizes electronic docbases, databases, and computer systems (Microsoft Office, Veeva Vault, Zinc, and web based applications)
- MS Office experience and competence required
At MRM//McCann, Relationship is our middle name.
We employ the most innovative talent in the industry to drive digital transformation for our clients’ businesses and provide creative solutions to help brands grow meaningful relationships with people.
MRM//McCann is a leading customer relationship agency that leverages the power of creativity, the beauty of data, and the magic of technology to help brands grow meaningful relationships with people.
Do you excel when working in a team? Are you fascinated by the endless possibilities that technology brings to marketing? Are you ready to transform our world?
We love our diverse workplace! MRM//McCann is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status or any other occupationally irrelevant criteria.
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