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