Clinical Project Publishing Manager Job

CLINICAL PROJECT PUBLISHING MANAGER needed for a CONTRACT opportunity with Yoh's client located in BRIDGEWATER, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- BA/BS degree in the sciences, preferably in a health-related field, or equivalent theoretical/technical experience.
- Minimum four (4) years experience in Regulatory Affairs or equivalent.
- Experience publishing with eCTD Manager.

WHAT YOU'LL BE DOING:

- This position will be responsible for managing publishing tasks associated with the compilation and dispatch of eNDA and eBLA and IND type submissions as well as all associated regulatory transactions to North American Regulatory Agencies.
- In addition, this position will have responsibility for providing support in managing publishing tasks associated with the compilation of all European submission (electronic and paper submission) activities on an as-needed basis.
- This position will be responsible for the coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Global Publishers.
- This position will work in close collaboration with the Global Publisher, Coordinators, including regularly providing up to date status reports and reporting of issues in a timely manner.
- This position will support all eNDA/eBLA submission types as well as all associated regulatory transactions to North American Regulatory Agencies.
- This will ensure proper cross-training and support of submission timelines.

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS degree in the sciences, preferably in a health-related field, or equivalent theoretical/technical experience.
- Minimum four (4) years experience in Regulatory Affairs or equivalent.
- Experience publishing with eCTD Manager.
- Thorough and current understanding of FDA, ICH and other appropriate regulations pertaining to regulatory and technical requirements for electronic documents and all types of submission dossiers (format and structure).
- A working understanding of electronic submission production tools.
- Thorough understanding of information management concepts and tools needed to support business area.
- Demonstrated understanding and experience with computer and information systems, electronic document management, and information management required.
- Full Awareness of evolving regulatory requirements and guidances (eg electronic submissions) that may impact submission standards.
- Practical understanding of evolving technologies in support of business area. Leadership and management skills with the ability to manage simultaneous priorities, changing deadlines, and limited resources required.
- Highly developed interpersonal, communication, negotiation, facilitation and leadership skills are required

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Krista Leach

Yoh, a DayJ2W: PROF; MONJOB

TAX TERM: CON_W2 J2WMIDATL

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SFSF: LS