Regulatory Submission Manager Contractor (remote)
Company: Remedy Solutions
Location: Cambridge
Posted on: May 11, 2022
Job Description:
Regulatory Submission Manager Contractor (remote)
- 1 Main St, Cambridge, MA 02142, USA
- Contract Company Description Remedy Solutions is a dynamic
recruiting firm representing US and International companies. Job
Description A pharmaceutical company is seeking a Regulatory
Submission Manager Contractor to work remotely for 40 hours a week
under a twelve (12) month contract. Responsibilities include
supporting processes related to the document formatting, planning,
compilation, and dispatch of routine regulatory submissions to
Health Authorities worldwide and participate in various activities
as part of a dynamic and evolving Regulatory Operations team. Role
and Responsibilities
- Act as the Regulatory Operations representative on submission
project teams and support regulatory documentation users and
contributors in the preparation of submission deliverables,
- Experience with electronic -Common -Technical Document (eCTD)
publishers and templates,
- Provide expert-level document formatting on MS Word
documents,
- Train users on StartingPoint templates,
- Publish and submit electronic submissions (and paper
submissions, when required),
- Create and maintain archives of communications with Health
Authorities,
- Identify and escalate issues which may impact submission
timelines and goals,
- Contribute to the writing, review, and implementation of
standards, templates, and procedures related to the publishing,
review, transmittal, and archiving of electronic regulatory
documentation; help implement associated process improvements.
Qualifications Qualifications and Education Requirements - B.S. in
a scientific discipline or an equivalent combination of education,
training, and experience. Candidates must have a minimum of 5 years
of experience in Regulatory operations. Preferred Skills -
Extensive experience with Microsoft Word, StartingPoint Templates,
ISI/TRS/DXC Toolbox, Adobe Acrobat, and electronic publishing
software (ARIM/RIM Smart preferred.) - Experience using electronic
document management systems. Veeva RIM/Submissions Vault preferred.
- Thorough knowledge of CTD/eCTD format and regulatory submission
requirements - Experience compiling IND, NDA, and other CTD
submissions - Experience with SharePoint - Strong attention to
detail and the ability to manage multiple tasks - Strong team
player that has a customer service approach and is solution
oriented. - The ability to work individually, within a
multi-disciplinary team, as well as with external partners and
vendors. Additional Information - This is 40 hour a week contract
for 6 months renewable up to 12 months. - Candidate will be an
independent contract receiving 1099 payment. - Candidate must have
USA permanent work authorization. No sponsorship for work visas is
available. - All of your information will be kept strictly
confidential according to EEO guidelines. Regulatory Submission
Manager Contractor (remote)
Keywords: Remedy Solutions, Cambridge , Regulatory Submission Manager Contractor (remote), Executive , Cambridge, Massachusetts
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