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Regulatory Submission Project Management Specialist

Term: 12-month renewable (CONTRACT TO HIRE)

Target Pay: $30-$36/HR

Must have recent PHARMA regulatory experience, preferably working on submissions.

The Temp Regulatory Submission Project Management will provide support to the Regulatory Submission Management (Reg SM) group by working on routine regulatory submissions, responsible for tracking deadlines for various regulatory obligations, and assist with submission work for major submissions such as INDs, CTAs, BLAs and supplements, MAAs and variations.

A typical day may include:

+ Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces

+ Provides support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572)

+ Coordinates publications (literature references) for submissions across all programs

+ Tracks submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissions

+ Manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status

This role could be for you if you have:

+ Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

+ experience with eCTD knowledge.

+ Experience in submission processes and systems

+ Ability to work with firm deadlines and adapt quickly to changing priorities

+ Expertise in document management

+ Strong knowledge with MS Office applications, Adobe Acrobat, electronic document management systems (eDMS) required.

To be considered for this role, you must have a Bachelor’s Degree with 0-2 years of relevant industry experience.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.