Experienced Medical Writer II for Clinical Study Report Development

19 hours ago

Remote, India beBeeMedicalWriter Full time ₹ 1,04,000 - ₹ 1,30,878

Seeking an Experienced Medical Writer II to Compile and Edit Clinical Study Reports

Job Description
  • Write, compile, and edit medical documents with minimal supervision.

As a seasoned Medical Writer II, you will develop and produce high-quality clinical study reports, narratives, and other medical writing deliverables. This role requires expertise in writing CSR Narratives and the ability to mentor less experienced writers.

Required Skills and Qualifications
  • 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.
Key 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.
  • Stay updated with regulatory guidance and client expectations in medical writing.

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