Regulatory Submissions Project Manager job in United States, Oak Ridge

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This vacancy has now expired. Please see similar roles below...

At Proclinical, we are recruiting for a new, permanent Regulatory Submissions Project Manager position, based in Oak Ridge, NJ. The right applicant will drive multiple New Drug Application submissions and programs with little oversight by senior management. The Project Manager will act as a central contact for program information, and will manage and develop relevant activities and programs, as well as ensuring cooperation and concurrence between teams and management, to meet objectives and goals. The applicant will work with management and staff alike, to create development strategy for submissions, establish working objectives, and monitor overall progress, in addition to recommending project objectives, requirements, and scientific direction to all staff.

Responsibilities

Provide regulatory project management and support for all relevant areas.
Apply NDA and/or eCTD submission experience to the development and oversight of the strategic implementations of electronic regulatory submissions processes and systems.
Support project teams toward implementation of submission plans and track progress to goals.
Assure adequate representation of Regulatory Affairs in relevant groups.
Responsible for maintenance of all project aspects.
Maintain regulatory submission and project schedules using Microsoft Project.
Facilitate project review with senior management, and make recommendations for forward action to achieve goals and objectives.
Manage project information.
Ensure smooth action point transitions.
Support quarterly forecasts, manages scopes, timeline and financial changes through tracking variances at the program level.
Work with relevant areas/teams to lead the development of strategy and project plan.
Manage and track program progress continually, and work with manager and project team to achieve timely resolution of any problems or issues.
Responsible for ensuring the availability of comprehensive project and program information to management and wider organization.

Skills And Requirements

Bachelor’s degree in science or relevant field (MBA or graduate-level degree preferred).
5+ years pharma experience.
Project management skills.
Working knowledge of regulatory interactions.
Experience with and knowledge of the drug manufacturing process.
Fluency in Microsoft Project.
Exceptional verbal and written communication skills, with high level of attention to detail.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 6463672618 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.