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Specialist, Document Control and Records Management

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Aug 7, 2022

View more

Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

The Role:
The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations. The individual will be responsible for formatting and administration of paper-based and electronic document workflows. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.

Heres What Youll Do:

  • Support cross functional teams in processing document requests, document approval, and document archival

  • Formatting, coordination, and issuance of electronic documentation in eDMS (Veeva)

  • Business administration tasks within eDMS

  • Assist in document control process improvements with Document Types, Lifecycles, and Workflows in eDMS

  • Maintain periodic review process for documents

  • Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents

Heres What Youll Bring to the Table:

  • A minimum of two years of Quality Assurance experience in pharmaceutical industry providing Quality Assurance oversight with a BS degree; 0-2 years of experience with MS degree

  • Ability to translate complex issues into a meaningful set of recommendations

  • Demonstrated knowledge of cGMPs in a manufacturing environment

  • Strong independent judgement and decision-making abilities

  • Demonstrated problem detection and problem resolution skills

  • Must possess demonstrated organizational skills

  • Must possess excellent verbal and written communication skills

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    Vacation, sick time and holidays
    Volunteer time to participate within your community
    Discretionary winter shut down
    Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 persons 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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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Find Us
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States
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