Clinical Research Document Specialist

1 day ago

Hubli, Karnataka, India beBeeResearch Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Opportunity: Medical Writer/Clinical Study Researcher

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We are seeking a skilled Medical Writer/Clinical Study Researcher to join our team. As a key member of our clinical research documentation team, you will be responsible for developing high-quality clinical trial documents that support drug development and approval processes.

\Main Responsibilities:\
  • \
  • Develop key clinical trial documents, including protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs).\
  • Translate complex scientific data into clear, regulatory compliant documents that meet industry standards.\
  • Craft abstracts and manuscripts, demonstrating strong scientific communication skills.\
  • Prepare protocols, CSRs, Patient Information Sheets-Informed Consent Forms (PIS-ICFs) and CRFs.\
  • Understand study objectives and design protocols.\
  • Prepare and review Standard Operating Procedures (SOPs).\
  • Collaborate with cross-functional teams to ensure effective and complete documentation within the timeline.\
  • Stay up-to-date with regulatory requirements and industry best practices.\
  • Contribute to the development of policies and procedures related to clinical trial documentation.\
  • Ensure compliance with company policies and procedures.\
  • Perform other tasks as required.\
  • Bachelor's degree in a relevant field such as Life Sciences, Healthcare, or Science Writing.\
  • Minimum 3 years of experience in medical writing or a related field.\
  • Proven track record of delivering high-quality clinical trial documents on time and within budget.\
  • Strong scientific knowledge and understanding of regulatory requirements.\
  • Excellent communication and interpersonal skills.\
  • Ability to work independently and collaboratively as part of a team.\
  • Proficiency in MS Office, especially Word, Excel, and PowerPoint.\
  • Familiarity with electronic document management systems.\
  • Strong attention to detail and organizational skills.\
  • Ability to multitask and prioritize multiple projects simultaneously.\
  • Flexibility to adapt to changing priorities and deadlines.\
  • Passion for scientific writing and commitment to delivering high-quality work products.\
  • Continuous learning and professional development opportunities.\
  • A dynamic and supportive work environment.\
  • A competitive salary and benefits package.\

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