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Regulatory Operations Senior Specialist
2 months ago
The Regulatory Operations Senior Specialist is responsible for adhering to the protocols set forth by our pharmaceutical clients during the submission of marketing materials for regulatory assessment. This role involves preparing comprehensive editorial content for the Medical-Legal-Regulatory (MLR) review board, which consists of professionals such as medical doctors, legal experts, and specialists in FDA regulations. The specialist will manage the submission of materials to clients, ensuring compliance with their specifications, and will monitor the progress of each project through the various phases of MLR review.
Key Responsibilities:
- Assess the time and resources necessary for each submission.
- Develop a timeline and delegate responsibilities to team members for the delivery of submission components.
- Oversee the creation of submission materials, ensuring adherence to client and Publicis Health standards.
- Maintain an accurate and detailed dashboard of all ongoing and upcoming submissions, including review stages, job codes, and deadlines.
- Communicate promptly with client representatives to ensure timely receipt of submissions that meet all client expectations.
- Serve as the main liaison between the agency and the clients' MLR Review department, providing information on submission requirements and addressing procedural inquiries.
- Develop, update, and share procedures specific to the clients supported with the department.
Qualifications:
A minimum of a bachelor’s degree along with 2-4 years of experience in preparing complex deliverables under stringent deadlines is essential. Proficiency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite is required. Direct client communication experience is necessary. Strong attention to detail and clear communication skills are critical. Preferred qualifications include clear and concise technical writing abilities, as well as experience in the Pharmaceutical or Healthcare sectors.
Additional Information:
All information will be kept confidential in accordance with EEO guidelines.
Compensation Range: $24.52- $36.06/hr. This range reflects the anticipated pay for this position at the time of posting. Compensation will be determined based on the applicant's skills, qualifications, and experience, as well as the position's requirements. The company reserves the right to adjust this pay range at any time. This role may be eligible for participation in a freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria are met. Additionally, this role may qualify for participation in a 401(k) plan after meeting eligibility criteria.
