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System One Services Senior Manager, Regulatory Informational Management in Gaithersburg, Maryland

Senior Manager, Regulatory Informational ManagementGaithersburg , MD

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:218573

Date Posted:04/07/2021

Job Title: Senior Manager, Regulatory Informational Management, Regulatory Affairs Operation (https://novavax.applicantpro.com/jobs/1720995.html) s

Address: Remote Role!

Type: Direct - permanent

Client's job description:

We are seeking a highly motivated and experienced individual to join our team as a Senior Manager for Regulatory Informational Management, Regulatory Affairs Operations. The Senior Manager, RIM, Regulatory Affairs Operations will support the Research & Development organization by leading or participating in projects and initiatives that optimize the use of information technology to achieve Regulatory Informational Management, Regulatory Affairs Operations, R&D, and strategic & tactical business objectives. The position will work in close collaboration with the Head of Regulatory Affairs Operations to define, implement, and lead COMPANY'S Regulatory Information Management (RIM) program to support day-to-day regulatory and global development operations in the United States, Europe, and worldwide. This role regularly collaborates with regulatory & business leadership, business process owners, business analysts, and information technology specialists to design and/or improve business processes, introduce and/or maintain data and process standards, implement new systems or enhance existing systems, and effectively administer & operate current systems. This role often involves the oversight of internal or contracted staff and leadership or direct management of projects and initiatives.

This position is located in Gaithersburg, MD facility and reports to the Head of Regulatory Affairs Operations.

Responsibilities include but are not limited to:

Research, develop, and lead by:

  • RIM Projects & Initiatives: Provide leadership and expertise in the execution of business process-related tasks and deliverables required to implement or improve regulatory and R&D business processes and information technology capabilities.

  • Assess and oversee implementation of Commercial Off the Shelf (COTS) RIM Systems.

  • Develop and maintain templates, metadata, and Standard Operating Procedures (SOPs) related to RIM activities.

  • Provide intra- and inter-departmental training on RIM systems and processes.

  • Establish appropriate regulatory metrics for RIM.

  • Working Groups and Teams: Lead and/or contribute to Regulatory Affairs, Regulatory. Affairs Operations, or RIM working groups and teams formed to address areas of improvement within the Regulatory and R&D scope of operations.

  • System Administration & Operational Support: Define, monitor, and improve the administrative and operational business support of RIM Systems including, but not limited, to procedural documents, user testing & training, and issue resolution.

  • Process & Data Standards: Identify, contribute, and lead efforts to standardize RIM data and processes to enable information management efficiencies regionally and globally.

  • Maintain COMPANY'S regulatory master data in relevant regulatory authority databases.

  • Special Projects or assignments: Lead or contribute to ad hoc RIM projects or assignments, as necessary.

Minimum requirements:

  • BS or MS in a related science field (e.g., life sciences, computer science, or information technology) strongly preferred.

  • 8 or more years' experience in the biotechnology or pharmaceutical industry.

  • Ability to work independently and within a group setting and to interact effectively with different functional departments across the organization.

  • Shows strong initiative and drive; must be an organized self-starter.

  • Prior leadership experience strongly preferred.

  • Comprehensive knowledge of the global biologic and drug development process, including applicable laws, regulations, and guidelines strongly desirable.

  • Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are essential.

  • Hands-on working knowledge including technical/electronic background, experience in regulatory submissions and publishing activities, and secure product lifecycle management is essential.

  • Must be able and willing to work in a fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills.

  • Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs.

  • Ability to solve problems independently.

  • Demonstrates flexibility in dealing with change and diversity.

  • Possesses strong critical and logical thinking skills.

  • Ability to communicate and work successfully within a cross-functional team.

  • Excellent interpersonal and communication skills.

  • Must be able to interact, communicate, and present technical information to individuals at all levels of the organization.

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