Document Control Specialist

The Role:

Reporting to the Director, Global QA Operations, the Manager, Document control will be responsible to manage and maintain GxP controlled documents for technical development in the e-DMS system, in line with internal and external requirements.

Heres What Youll Do:

• 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

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

• Formatting, coordination, and issuance of electronic documentation in eDMS

• Business administration tasks within eDMS

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

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

• Monitor and oversee management and formatting of GxP controlled documents.

• Support regulatory filing as appropriate

• Provide hands-on support in the day-to-day management of documents and systems within the GxP Quality Management System using digital solutions

• Work with the digital team and provide guidance to streamline, create efficiency and improve procedures.

Heres What Youll Bring to the Table:

• Bachelor or MS degree in Education

• 5+ years experience managing GxP and technical controlled documents in Pharmaceutical/Biotech industry.

• Working knowledge of applicable FDA, EU regulations and ICH standards/guidelines applied to development of process or analytics.

• Working experience of quality systems and e-systems in a biopharma organization.

• Proficiency in Good Documentation Practices.

• Strong skills in CSV and Data Integrity.

• Advanced proficiency in Word, Excel, and PowerPoint to build and maintain various kinds of reports, process maps and presentations

• Ability to interact effectively with operational and leadership level of the organization.

• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.

• Outstanding communication skills (verbal and written).

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

• A digital first and curious mindset that allows you to constantly learn and challenge the status quo.

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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