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ICON plc

1 -3 Years

Bangalore

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.

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ICON plc is a world-leading healthcare intelligence and clinical research organization. The company is dedicated to fostering an inclusive environment that drives innovation and excellence. ICON plays a key role in shaping the future of clinical development and is seeking a highly skilled and experienced Bioanalytical Report Writer to join their team in Bangalore, India.

Responsibilities of the Analytical Writer Role

As a Bioanalytical Report Writer at ICON, you will be responsible for compiling, interpreting, and writing bioanalytical study reports for clinical and preclinical research projects. Your key responsibilities will include:

  • Report Writing: Compile bioanalytical study reports ensuring clarity, accuracy, and compliance with regulatory standards.
  • Data Interpretation: Analyze data obtained from bioanalytical methods, including Sandwich and Bridging ELISA and LCMS.
  • Regulatory Compliance: Ensure reports meet FDA, EMA, and ICH M10 guidelines, focusing on quality, integrity, and consistency.
  • Collaboration: Work closely with clinical, preclinical, and laboratory teams to gather necessary data for report writing.
  • Scientific Accuracy: Review and edit reports for scientific accuracy, consistency, and regulatory compliance, while adhering to GLP and GCP guidelines.
  • Documentation: Prepare study protocols, raw data reports, and final study reports. Participate in discussions related to study design and data collection.

Qualifications Required for Analytical Writer Position

ICON is looking for candidates with a solid background in clinical research and bioanalytical techniques. The essential qualifications for this position are:

  • Education: Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
  • Experience: A minimum of 1-3 years in bioanalytical report writing, particularly in clinical and preclinical settings. Experience in a Clinical Research Organization (CRO) or similar laboratories is preferred.
  • Bioanalytical Methods Expertise: Knowledge of Sandwich and Bridging ELISA and LCMS methods.
  • Regulatory Knowledge: A solid understanding of FDA, EMA, and ICH M10 guidelines for bioanalytical studies.
  • Report Writing Experience: Demonstrated experience in writing bioanalytical study reports in accordance with GLP, GCP, and other regulatory standards.

Skills for Success in the Analytical Writer Role

The ideal candidate for the Analytical Writer position at ICON should possess the following skills:

  • Data Interpretation: Ability to interpret complex bioanalytical data and present it in clear, concise reports.
  • Communication: Excellent written and verbal communication skills to collaborate with internal and external stakeholders.
  • Attention to Detail: Strong attention to detail to ensure the accuracy of reports and data analysis.
  • Time Management: Ability to prioritize tasks and meet deadlines in a fast-paced environment.
  • Familiarity with Clinical Trials: Knowledge of clinical trial processes, pharmacokinetics, pharmacodynamics, immunogenicity, and bioanalytical data analysis.

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