Sr. Document Associate, Regulatory Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
August 14 2019
Ref
R1814
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr. Document Associate, Regulatory Operations

The Role:

This role is an exciting opportunity to be an integral part of the talent engine fueling a high growth organization that is radically changing the biotech industry. Reporting to the Senior Director, Regulatory Operations, the Senior Document Associate, Regulatory Operations will be responsible for document formatting, publishing, quality control, enabling use of the Regulatory document management system, and interactions with third party vendor(s) to ensure compilation of high-quality electronic submissions.

Here's What You'll Do:
  • 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.
  • Lead the update of publishing processes and SOPs.
  • Create and provide training to regulatory and cross functional colleagues on the use of Regulatory Systems (e.g. Document Management, eCTD Review tools) and related processes.
  • Act as a business administrator of Moderna's Document Management System.


Here's What You'll Bring to the Table:
  • Bachelor's degree with relevant experience, including electronic document management systems, global regulatory systems, other experience directly related to Regulatory Operations (2-5 years minimum).
  • Experience publishing eCTD, and other submission types, for submission to the FDA, and EMA, and other health authorities.
  • Strong organizational skills.
  • 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.
  • Extensive experience working with document management systems and publishing tools


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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