Medical Writing II (CSR Narrative, QC review)

Medical Writer II

Roles and Responsibilities

• Mentor less experienced medical writers on projects.
• Compile, write, and edit medical writing deliverables with minimal supervision.
• Develop or support a variety of documents, including

  Clinical Study Protocols, Clinical Study Reports (CSRs), Patient Narratives

  , and Investigator Brochures.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, and consistency.
• Interact with various departments such as data management, biostatistics, and regulatory affairs to produce deliverables.
• Serve as a peer reviewer on internal teams, ensuring document scientific content, clarity, and proper formatting.
• Adhere to established regulatory standards, including

  ICH-E3 guidelines

  , and company SOPs.
• Perform online clinical literature searches as applicable.
• Maintain awareness of project budget specifications and communicate changes to leadership.
• Stay updated with regulatory guidance and client expectations in medical writing.

Skills Required

• Strong experience in medical writing, with a minimum of 3 years of relevant experience in

  Narrative writing

  .
• Proven experience in independent authoring and reviewing

  CSR Narratives

  .
• A Bachelor of Science or a Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific and/or medical knowledge.
• Extensive knowledge of

  English grammar

  and

  FDA and ICH regulations and guidelines

  .
• Familiarity with

  AMA style guide

  .
• A high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
• Strong proficiency in

  Word, Excel, PowerPoint

  , email, and the Internet.
• A working knowledge of the drug development process and regulatory guidelines.
• The ability to interpret and present clinical data and other complex information.