Sr. Medical Writers for biopharmaceutical/CRO

1 week ago

Ahmedabad, Gujarat, India The Leaders Hive Full time

Role Summary: As a Senior Medical Writer, you will be responsible for conducting comprehensive literature reviews on assigned topics and delivering high-quality scientific content to support cross-functional teams throughout the clinical study lifecycle. You will contribute to the development of clinical and regulatory documents, ensuring alignment with project timelines, scientific integrity, and regulatory compliance. Your role will involve close collaboration with various departments to provide scientific insight and ensure the accuracy and clarity of all written materials.

Job Role

Senior Medical Writers

Department

Medical Writing

Location

Hybrid

Education

B Pharma or M Pharma or MD or PhD in Lifesciences

Years Of Experience

5+ years of Medical Writing experience in the biopharmaceutical/CRO industry is required

No. of Documents prepared Protocol : Minimum 10, CSRs : Minimum 10 , IB's : Min 2, Manuscript : Minimum 5

Skills Required

  • Proficiency in organizing and communicating clinical information
  • Excellent attention to detail, consistency, clarity and scientific rigor
  • Continuous improvement and growth mindset
  • Ability to work in a fast-paced and changing environment
  • Accountable, focused, precise attitude
  • Customer-service mentality and can-do attitude
  • Exceptional command of written and spoken English at a professional level with the ability to write clear, concise and grammatically flawless medical/scientific content.

Qualifications

  • Experience in medical writing for Oncology, Hematology, Infectious Diseases, and/or Autoimmune Disorders is strongly preferred.
  • Experience in Phase I-III studies

Sr No.

Job Responsibilities

Works closely with cross-functional project teams to independently author scientifically accurate, comprehensive and compliant documents, including but not limited to clinical study reports, clinical study protocols, manuscripts, informed consent forms, patients' narratives, abstracts, posters, oral presentations, etc

Manages the collection, consolidation and integration of comments/feedback from internal and external reviewers to efficiently finalize assigned writing projects

Performs thorough quality control checks, including copyediting, proofreading, and cross-verification of data within clinical documents and against source TFLs to ensure accuracy, consistency, and compliance with regulatory standards.

Ensure that the assigned deliverables strictly adhere to regulatory guidelines (e.g., ICH-GCP, EMA/FDA requirements), publication guidelines (ICMJE, GPP, journal/congress-specific requirements), client specifications, and Veeda's quality standards for content, format, and structure.

Streamline the review process by identifying and mitigating potential conflicts early, enabling the timely completion of high-quality deliverables.

Provide supervision and technical advice to other medical writers in the team and new writers joining the team, as required.

Apply broad therapeutic knowledge to adapt writing style and content for different disease areas and target audiences

Conduct literature reviews on assigned therapeutic areas and provide scientific support across departments throughout the clinical study lifecycle, ensuring adherence to timelines and project requirements.

Quickly assimilate new therapeutic area information to support emerging project needs

Maintain awareness of evolving guidelines and standards across relevant therapeutic fields

Provide support to Medical Writing department activities as needed

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