Document AssociateApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
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.
- 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.
- 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.
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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