JVT Advisors

Document Associate

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 3-6 Months (with likely extension)

JOB SUMMARY: The Document Associate, Regulatory Operations will be responsible for assisting with document formatting, publishing, quality control, and interactions with third party vendor(s) to ensure compilation of high-quality electronic submissions.

Responsibilities:

  • Compile and submit eCTD, paper, or PDF submissions using publishing systems.
  • QC and format documents to ensure they meet submission-ready standards.
  • Ensure that documents are filed and archived properly in accordance with Moderna requirements.
  • Interact with third party vendor to ensure eCTD submissions are submitted on time and are free of validation errors.
  • Assist with the update of publishing processes and SOPs.

Requirements:

  • Bachelor’s degree with relevant experience, including electronic document management systems, global regulatory systems, other experience directly related to Regulatory Operations (1-2 years minimum).
  • Experience publishing eCTD, and other submission types, for submission to the FDA, and EMA, and other health authorities preferred.
  • Strong organizational skills and Critical thinking/problem-solving skills.
  • Ability to operate in a fast-paced environment and manage multiple activities, priorities and deadlines
  • Strong interpersonal skills to communicate and collaborate with multiple groups.
  • Proficiency with computer programs such as MS Office, Power Point, and Adobe Acrobat.

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Jordan Paulding

Recruiter

Jordan is a Sourcer for our Technology Practice. He loves making connections, building relationships and helping people improve their lives and careers.

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