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Pfizer

Makes cancer drugs, vaccines and other medicines

Medical Writing Manager

Regulatory & Quality (Life Sciences)Posted on Nov 12
Full-timeNo salary listed

About the Job

Requirements

  • A BA/BS or MBA/MS with some relevant experience; a PhD/JD with any relevant experience; an Associate's degree with strong relevant experience; or a high school diploma or equivalent with extensive relevant experience.
  • Demonstrated experience in document quality control and/or medical writing in the pharmaceutical or biotech industry.
  • Experience interacting with cross-functional study team members.
  • A solid understanding of medical terminology and clinical trials.
  • Excellent interpersonal and communication skills.
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.
  • Proficiency with Microsoft Office applications.

Responsibilities

  • Lead or co-lead moderately complex projects, managing time and resources effectively.
  • Apply skills and knowledge to contribute to departmental work.
  • Make decisions to resolve moderately complex problems and operate independently in ambiguous situations, guided by policies.
  • Work independently on assignments, receiving guidance on unusual or complex problems.
  • Review own work, seek feedback from others, and mentor colleagues by reviewing their work.
  • Use judgment and experience to potentially become a resource for others.
  • Collaborate with project team experts to develop document strategies and messages.
  • Ensure documents meet internal standards, are submission-ready, and are properly stored.
  • Verify document accuracy using source materials, including clinical regulatory documents and data.
  • Lead teams of authors for complex projects, perform quality control reviews, and contribute to colleague training on quality standards and processes.

Desired Qualifications

  • A Master's degree is highly desirable.
  • Proficiency in software commonly used for data presentation and analysis.
  • Strong problem-solving skills and the ability to operate independently in ambiguous situations.
  • Experience leading or co-leading projects.
  • Experience training colleagues on quality standards and processes.
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem-solving and enhance productivity, along with curiosity about how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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