ProClinical Staffing

This role is crucial in ensuring that timelines and deliverables for NDA/MAA filings are mutually understood and agreed upon.. Proficiency in technical systems such as Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.. Experience with regulatory filings, original NDA/BLA/MAA, and response to questions is a plus.. Maintain real-time filing timelines and track deliverables through NDA/MAA submission and registration.. Develop document reviewer matrix and coordinate reviews and roundtables as needed.

project management

Senior Manager, Regulatory Project Management - Contract - Cambridge, MA Proclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA. Primary Responsibilities:
The role is focused on R&D project management for late-stage global regulatory filings. The successful candidate will be responsible for developing and optimizing detailed regulatory project plans and timelines, maintaining real-time filing timelines, and facilitating critical filing team meetings. This role is crucial in ensuring that timelines and deliverables for NDA/MAA filings are mutually understood and agreed upon. Skills & Requirements:
Bachelor's degree in a scientific or medical field preferred with at least 6 years' experience in the biotechnology or pharmaceutical industry.
Demonstrated project management skills with the ability to prioritize multiple projects.
Experience developing project plans, content plans, and other filing tools.
Proficiency in technical systems such as Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.
Excellent organizational and meeting management/facilitation skills.
Excellent written and verbal communication skills, including negotiation skills.
Ability to work in a fast-paced environment and driven to succeed.
Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion.
Working understanding of regulations and experience in interpretation of Health Authority guidelines.
Experience with regulatory filings, original NDA/BLA/MAA, and response to questions is a plus. The Senior Regulatory Project Manager will:
Develop and optimize detailed regulatory project plans and timelines in collaboration with various leads.
Maintain real-time filing timelines and track deliverables through NDA/MAA submission and registration.
Facilitate and co-lead critical filing team and sub-team meetings.
Maintain project dashboard for sharing progress and risks with senior management.
Identify and highlight project interdependencies.
Develop document reviewer matrix and coordinate reviews and roundtables as needed.
Plan and facilitate cross-functional workshops focused on execution of submission strategy.
Coordinate lessons learned sessions and ensure implementation of feedback for process improvement.
Contribute to the development of best practices and standardized process for filing of NDA/MAAs. If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.

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