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Full-Time

Senior Manager

Clinical Compliance

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior, Expert

Cambridge, MA, USA + 2 more

More locations: Princeton, NJ, USA | Bethesda, MD, USA

Multiple in-office locations available in Cambridge, Massachusetts; Princeton, New Jersey; and Bethesda, Maryland.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
  • Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
  • Knowledge and understanding of ICH GCP and other applicable regulations/guidelines.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Responsibilities
  • Collaborate with cross-functional clinical trial teams to ensure all trials are conducted in compliance with internal policies and procedures, global and local regulations, and ICH/GCP.
  • Identify compliance risks, communicate risks, facilitate appropriate decision making with impacted functions, and escalate to management.
  • Collaborate with cross-functional team members to answer compliance questions or direct compliance issues to appropriate subject matter experts.
  • Keep abreast of regulatory developments across industry as well as evolving compliance best practices.
  • Ensure that compliance issues associated with clinical audits or inspections are properly evaluated and adequately addressed in collaboration with study teams and R&D Quality.
  • Support study teams with reporting of quality events, investigation of issues, root cause analysis, and CAPA plans.
  • Assist in developing and monitoring key performance indicators (KPIs) for the compliance function to measure success and identify areas for improvement.
  • Assist in driving continuous improvement initiatives within the clinical compliance function, utilizing new technologies and best practices.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

8%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.