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Regulatory Scientific Writer

0-5 years
Not Disclosed
10 May 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Regulatory Scientific Writer

About Us:

Aroga Biosciences is a renowned clinical research organization specializing in providing top-tier regulatory writing services for biotech and pharmaceutical projects. With a team of highly experienced scientists, we excel in delivering submission-ready documents across a wide range of therapeutic areas. Our focus on regulatory medical writing is driven by a passion for contributing to the development of novel therapeutics, ultimately benefiting patients worldwide.

Responsibilities:

  • Author, edit, and format regulatory documents, particularly nonclinical documents for IND submissions.
  • Ensure clarity, coherence, and accuracy of messaging in all documents.
  • Review technical content to identify gaps, risks, or challenges and provide constructive feedback.
  • Conduct literature searches and prepare literature reviews.
  • Present data effectively in text, tables, and figures.
  • Ensure document compliance with regulatory guidelines and industry standards.
  • Collaborate with project management personnel to develop document timelines and reviewer lists.
  • Lead document planning, including outlining, gathering relevant information, and managing timelines.
  • Initiate authoring and review cycles, routing documents for approval, and managing QC and publishing.
  • Maintain effective communication with clients and internal teams throughout the document lifecycle.
  • Lead project kickoff and comment resolution meetings.
  • Commit to personal professional development through training and independent research.

Requirements:

  • Bachelor’s degree in a medically relevant field or life science; MS or PhD preferred.
  • Experience authoring scientific documents with clear presentation of scientific data.
  • Ability to critically review scientific content for clarity and accuracy.
  • Strong communication, project management, and time management skills.
  • Flexibility to adjust to shifting timelines and demands.

Preferred Experience:

  • Familiarity with different document templates and style guides.
  • Experience with online collaborative authoring platforms.
  • Knowledge of drug development process and regulations.
  • Familiarity with IND contents, particularly nonclinical documents.

Benefits:

  • Competitive salary.
  • Comprehensive medical, dental, and vision insurance.
  • Flexible work week and hybrid work schedule.
  • 401K options.

For more information, visit www.arogabio.com.

Join us at Aroga Biosciences, where we are dedicated to excellence in regulatory medical writing and making a difference in healthcare.