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Full-Time

Sr. Specialist

PV Operations Global Case Management

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Junior, Mid

Cambridge, MA, USA

70/30 work model requires 70% in-office presence.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Google Cloud Platform
PowerPoint/Keynote/Slides
Requirements
  • Bachelor’s degree preferably in life science, nursing, pharmacy, or other healthcare related profession
  • Minimum of 2-3 years of direct pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
  • Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems
  • Knowledge of GCPs, ICH guidelines and FDA, EMA, MHRA, PMDA, and Health Canada and other international regulations and guidelines
  • Working knowledge of MedDRA and WHO Drug dictionaries
  • Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
  • Detail-oriented, with good organizational, prioritization of competing requests/projects, and time management proficiencies. Must be able to work on multiple projects simultaneously and independently
  • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
  • Proficient in standard computer software (Word, Excel, and Power point presentations)
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment
Responsibilities
  • Regularly monitor and manage global case management mailboxes
  • Communicate with vendors regarding Individual Case Safety Reports
  • Identify issues and collaborate with internal and external partners to come to a resolution
  • Schedule meetings and record minutes for multiple projects
  • Prepare and distribute communications and correspondence such as memos, emails, reports, meeting agendas
  • Support global case management in reconciliation activities
  • Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits. Be an active contributor during audits and inspections by preparing and reviewing responses
  • Participate in the development and maintenance of PV System policies, SOPs, work instructions, forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
  • Assist in safety database validation by performing user acceptance testing
  • Escalate issues to management as needed
  • Assist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives
  • Provide assistance for the development, maintenance, and delivery of training materials for internal and external groups, as needed

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

12%

2 year growth

53%
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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.

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