Simplify Logo

Full-Time

Senior Manager of Medical Writing Delivery and Excellence

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

Expected to be in office 70% of the time with flexibility to work from home up to 30%.

Category
Content Strategy
Technical Writing
Content & Writing
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelors degree with a minimum of 9 years of relevant experience.
  • Proven experience in clinical development, regulatory affairs, or medical affairs.
  • Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities.
  • Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view.
  • Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives.
  • Ability to lead functional projects or programs; Mentor and collaborate with colleagues with less experience.
  • Knowledge of best practices and how medical writing integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.
  • Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.
  • Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.
  • Proficiency in Microsoft Office and familiarity with medical writing software.
Responsibilities
  • Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of medical writing and regulatory writing within a clinical development program.
  • Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.
  • Oversee the timely and efficient progress of medical writing deliverables, ensuring that all deadlines are met.
  • Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.
  • Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards.
  • Interpret and present clinical data and other complex information.
  • Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents.
  • Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements.
  • Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.
  • Provide input into goals and objectives for the medical writing team that align with the company's overall strategy.
  • Responsible for management of direct reports (if applicable)

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%
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.