Document Specialist, Medical Writing Operations

The Role:

The Medical Writing (MW) Operations team at Moderna is looking for an agile, self-motivated individual to serve as a Document Specialist. This individual will be responsible for supporting the MW Operations team with the preparation of clinical and regulatory submission related documentation for electronic submissions and archiving. The successful candidate will be detailed oriented, self-directed, and with the ability to be flexible and manage workload to meet project timelines.

Here s What You ll Do:

• Perform technical formatting review and editing of clinical and regulatory documents for submission to regulatory agencies in accordance with company-specific SOPs, templates, and style guide, within established timelines.
• Ensure that format and content of clinical and regulatory documents comply with applicable submission formatting regulations.
• Assist in the remediation of PDF documents by bookmarking, hyperlinking, and reviewing to ensure compliant regulatory files.
• Assist in the review and development of document templates, as needed.
• Identify and appropriately communicate risks associated with document formatting and propose mitigation plans.
• Support the MW Operations team Lead in scheduling and tracking of document formatting tasks, as needed.
• Attend project-related meetings, as assigned.
• Complete project-specific and company training, as assigned.
  
  

Here s What You ll Bring to the Table:

• Bachelor s degree required. Life science or related allied health field preferred.
• Minimum of 3 years of document formatting experience in the biopharmaceutical industry.
• Working knowledge of GCP, FDA regulations, ICH guidelines (in particular ICH E3, E6, and E9)., and the drug development process.
• Familiarity with clinical study and submission documents such as protocols, Investigator Brochures, and CSRs.
• Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
• Project/time management and organizational skills, as well as the ability to work independently.
• Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
• Comprehensive Microsoft Office, especially Word but also Project, PowerPoint, and Excel skills.
• Ability to communicate with professionals from a variety of backgrounds.
• Attention to detail style, consistency, grammar, syntax, scientific accuracy.
  
  

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 year-end shutdown
• 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 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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