Full-Time

Senior Manager

Clinical Compliance

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA + 2 more

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

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Google Cloud Platform
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 crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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