Sr. Manager, Medical Writing (Remote)

Atara Biotherapeutics

South San Francisco California

United States

Healthcare - Allied Health
(No Timezone Provided)

Job Description

The Sr. Manager, Medical Writing will be responsible for the development of clinical, safety, CMC, and nonclinical regulatory documents and content across Atara’s product pipeline. This position collaborates with a variety of functional areas to prepare, deliver, and contribute to documents in support of global regulatory filings.

Reports to Sr. Director, Medical Writing

Work Location This position can be fully remote with at least a few trips per year to the Los Angeles office – Must be willing to work West Coast/Pacific time hours

Key Responsibilities:

  • Prepares/writes and manages the preparation of clinical, safety, CMC, nonclinical regulatory submission documents and content that complies with global regulatory requirements, including but not limited to briefing documents, requests for information, summary and overview documents, protocols, reports.
  • Drives the document development process from gathering materials, developing scientifically rigorous content, facilitating document review meetings and discussions, and assuring adherence to Atara style.
  • Contributes to the medical writing function with continuous improvement of internal processes, procedures, and templates that support efficient and compliant document preparation.
  • Qualifications

  • Doctorate degree with 3+ years of regulatory medical writing in a biopharmaceutical setting along with other scientific/technical writing experience; OR Bachelor’s degree with 7+ years of medical writing experience.
  • Experience in writing regulatory documents intended for worldwide use, which is based on an advanced knowledge of international regulations and guidelines governing the documents.
  • Familiarity with AMA Style guide and clinical research terminology.
  • Exceptional written communication skills including the ability to independently interpret and summarize complex results.
  • Excels in an environment where the full array of scientific/medical writing skills can be utilized.
  • Succeeds in a matrix team setting and meets or beats timelines every time.
  • Proficient editing skills along with expertise in Microsoft Office and Acrobat applications.
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
  • Sr. Manager, Medical Writing (Remote)

    Atara Biotherapeutics

    South San Francisco California

    United States

    Healthcare - Allied Health

    (No Timezone Provided)

    Job Description

    The Sr. Manager, Medical Writing will be responsible for the development of clinical, safety, CMC, and nonclinical regulatory documents and content across Atara’s product pipeline. This position collaborates with a variety of functional areas to prepare, deliver, and contribute to documents in support of global regulatory filings.

    Reports to Sr. Director, Medical Writing

    Work Location This position can be fully remote with at least a few trips per year to the Los Angeles office – Must be willing to work West Coast/Pacific time hours

    Key Responsibilities:

  • Prepares/writes and manages the preparation of clinical, safety, CMC, nonclinical regulatory submission documents and content that complies with global regulatory requirements, including but not limited to briefing documents, requests for information, summary and overview documents, protocols, reports.
  • Drives the document development process from gathering materials, developing scientifically rigorous content, facilitating document review meetings and discussions, and assuring adherence to Atara style.
  • Contributes to the medical writing function with continuous improvement of internal processes, procedures, and templates that support efficient and compliant document preparation.
  • Qualifications

  • Doctorate degree with 3+ years of regulatory medical writing in a biopharmaceutical setting along with other scientific/technical writing experience; OR Bachelor’s degree with 7+ years of medical writing experience.
  • Experience in writing regulatory documents intended for worldwide use, which is based on an advanced knowledge of international regulations and guidelines governing the documents.
  • Familiarity with AMA Style guide and clinical research terminology.
  • Exceptional written communication skills including the ability to independently interpret and summarize complex results.
  • Excels in an environment where the full array of scientific/medical writing skills can be utilized.
  • Succeeds in a matrix team setting and meets or beats timelines every time.
  • Proficient editing skills along with expertise in Microsoft Office and Acrobat applications.
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)