Full-Time

Senior Manager of Medical Writing Delivery and Excellence

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA

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

Category
Technical Writing
Content & Writing
Medical, Clinical & Veterinary
Requirements
  • Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelor's 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 explain difficult or sensitive information; work to build consensus.
  • 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 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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