Senior Manager, Regulatory Review - Multiple Open Positions

Job Description

The Sr Manager, Regulatory Review is responsible for managing a large team of Associates, Senior Associates and Managers to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review.

The Senior Manager plays a key role in establishing procedures for internal teams and advising on specific projects to aid smooth and fast review by clients.

The Senior Manager is responsible for identifying and solving potential issues across their account(s).

Additionally the Senior Manager, Regulatory Review must traffic, manage and assign all work flowing through their assigned brands to ensure the team is able to meet all deadlines.

DUTIES & RESPONSIBILITIES :

• Manage multiple direct reports at the Associate, Senior Associate, and Manager level including responsibility for interviewing, hiring, onboarding, training, and career development
• Provide estimates for SOW development
• Work with the Director, Regulatory Review in the development of departmental SOPs
• Oversee work of reporting employees on daily basis, providing advice on projects, and helping to address problems as they arise
• Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage
• Determine the time and effort required to complete each submission
• Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
• Create and / or oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
• Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
• Establish and manage role as primary point of contact with client MLR liason
• Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
• Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported

Qualifications

Minimum of a bachelor's degree and 5-8 years of experience in the preparation of complex deliverables under tight deadline constraints is required.

Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required. Experience communicating with clients directly is required.

Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience is preferred.

Clear communication and attention to detail are essential. Clear, concise technical writing ability is strongly preferred.

At least one year of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.