Full-Time

Associate Director

Medical Writing

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

Biotechnology
Healthcare

Senior

Cambridge, MA, USA + 1 more

More locations: Princeton, NJ, USA

Hybrid role with in-office presence expected in Cambridge, MA and Princeton, NJ.

Category
Technical Writing
Content & Writing
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • Advanced degree (preferred) with approximately 7 years of relevant experience OR bachelor’s degree with approximately 12 years of relevant experience.
  • Excellent interpersonal skills to effectively communicate and collaborate with all levels of the organization.
  • Ability to lead cross-functional projects or programs; manage external vendors.
  • Understanding of the business aspects of biotechnology and the ability to contribute to strategic planning.
  • Knowledge of external market and regulatory factors that may impact medical writing; ability to apply best practices to improve processes and services.
Responsibilities
  • Possess specialized depth and breadth of knowledge for managing medical writing and regulatory writing within a clinical development program.
  • Coordinate and oversee the planning, writing, editing, and review of clinical and regulatory documents.
  • Work closely with the clinical development team and other departments to ensure alignment and coherence of documents.
  • Ensure that all documents comply with regulatory guidelines and standards.
  • Understand and interpret complex clinical data and other scientific information.
  • Establish and maintain processes to ensure the quality of documents.
  • Regularly update and maintain all clinical and regulatory documents.
  • Lead others to solve complex problems using multiple sources of information; use sophisticated analytical thought to exercise judgment and identify solutions.
  • Guided by functional plans, achieve end results and contribute to policy development and planning.
  • Set goals and objectives for the medical writing team that align with the company's overall strategy.
  • Manage performance, develop talent, and allocate resources to ensure the successful execution of the department’s medical writing strategy.

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

15%

2 year growth

53%
Simplify Jobs

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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