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5-8 years
Not Disclosed
1 Dec. 10, 2024
Job Description
Job Type: Full Time Education: M.Pharm / P.hd Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Report Writer

Experience Required: 5–8 Years
Educational Qualification: M.Pharm / Ph.D.
Location: Ahmedabad


Job Description

We are seeking an experienced Report Writer to join our team in Ahmedabad. The ideal candidate will be responsible for preparing high-quality scientific documents and reports for clinical and pharmaceutical research projects. This role demands precision, a deep understanding of the subject matter, and the ability to present complex information in a clear and concise manner.


Key Responsibilities

  • Scientific Report Preparation: Draft, edit, and finalize clinical study reports, protocols, and summaries, ensuring accuracy and adherence to regulatory standards.

  • Data Analysis and Interpretation: Collaborate with data analysts and researchers to interpret results and incorporate findings into comprehensive reports.

  • Regulatory Documentation: Prepare and review documents required for regulatory submissions, including IND, NDA, and other filings.

  • Compliance Adherence: Ensure all reports and documents comply with global regulatory requirements, company guidelines, and Good Documentation Practices (GDP).

  • Research and Literature Review: Conduct in-depth literature reviews to provide context and support for scientific claims and research findings.

  • Collaboration: Work closely with project teams, including scientists, statisticians, and regulatory affairs professionals, to ensure timely delivery of documents.

  • Continuous Improvement: Stay updated on industry trends, guidelines, and best practices to enhance the quality and efficiency of report writing processes.


Candidate Requirements

  • Educational Background:

    • Master’s degree in Pharmacy (M.Pharm) or Doctorate (Ph.D.) in a related field.

  • Experience:

    • 5–8 years of experience in scientific writing, report generation, or regulatory documentation within the pharmaceutical or clinical research industry.

  • Technical Skills:

    • Proficiency in medical and scientific terminology.

    • Strong command of MS Office tools, particularly Word, Excel, and PowerPoint.

    • Familiarity with regulatory requirements (FDA, EMA, ICH guidelines) and submission processes.

  • Soft Skills:

    • Excellent written and verbal communication skills.

    • Strong analytical and organizational abilities.

    • Attention to detail and ability to manage multiple projects under tight deadlines.


Why Join Us?

  • Be a part of a leading organization at the forefront of pharmaceutical research.

  • Engage in challenging projects with opportunities for professional growth.

  • Work in a collaborative and innovative environment.

  • Competitive salary and comprehensive benefits package.

If you have a passion for scientific communication and a drive to contribute to groundbreaking research, we would love to hear from you. Apply now to join our team in Ahmedabad!