32 Regulatory Submissions Jobs

Position Title: Scientific Writer

Team: Regulatory Science Operations

Job Type: Contract

Job Location: Hyderabad (Hybrid)

Job Description

This is an exciting opportunity for a highly motivated individual to join Regulatory Science as a Scientific Writer and to be part of the Regulatory Sciences Operations team. The Scientific Writing Team drafts study reports and study summaries to support regulatory submissions for both biotech and crop protection products. This role will have a high emphasis on analytical chemistry. Scientific Writers collaborate closely with stakeholders and customers including Study Directors and Monitors, Subject Matter Experts, Quality Assurance, Statisticians, and Global Registration Teams. 

Job Summary

• Draft high-quality study reports and study summaries to support regulatory submissions for both biotech and crop protection products (this role work with analytical chemistry reports primarily). Strong scientific writing skills and a background in science (specifically analytical chemistry) is needed for drafting reports.
• Perform quality control reviews on draft reports and/or raw data. An understanding of Good Laboratory Practice (GLP) is required.
• Develop new report templates, optimize processes, and assess stakeholder feedback for continuous improvement.
• Coordinate peer reviews and Quality Assurance audits, collate comments, and facilitate finalization of reports and audit responses.   
• Communicate effectively with key stakeholders and customers. Partnership with stakeholders and customers to understand regulatory reporting requirements is important for success.

Job Qualification

• MSc (with knowledge in chemistry, biochemistry, or analytical chemistry); industry experience is preferred. Other degrees may be considered if proficiency in critical skills is demonstrated.
• Hands-on experience in different HPLC (or analytical) techniques, Interpret the test results with high accuracy from the raw data.
• Knowledge on writing protocols/ reports based on study (HPLC or other analytical test) findings.
• 2 to 7 years of relevant experience
• The ideal candidate will have experience in analytical chemistry
• Highly proficient in English, both spoken and written.
• Excellent verbal communication skills, which includes the ability to work effectively in a team environment.
• Excellent written communication skills, which includes strong keyboard and data entry skills and strong knowledge of Microsoft Word, Excel, Outlook, and Adobe Acrobat.
• Excellent attention to detail and ability to work on several projects simultaneously, efficiently, and independently.
• Excellent interpersonal skills with the ability to interact with a diverse set of stakeholders.
• Ability to work a partially-modified schedule to ensure overlap with our US-based teams, facilitating real-time collaboration and communication during key business hours.