Scientific Writer • Global Scientific Communications Toxicology Non-clinical submissions
6/9/20261 min read
Roles and Responsibilities
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position can change over time and can include additional responsibilities not specifically described in the job description.
Document Preparation, Development and Finalization/Document Management
Plan (including organizing/preparing outlines), write (including transferring data and authoring in a templated report format), edit, review, coordinate, and complete the ADME study reports supporting nonclinical development/product registration.
Ensure data are presented in a clear, complete, accurate, and concise manner
Conduct effective submission/document initiation meetings to ensure nonclinical team alignment and understanding
Ensure that key data, statements and conclusions are consistent across all related nonclinical documents
Format/Publish nonclinical deliverables as per regulatory standards
Project and Stakeholder management
Lead the submission process and apply effective project management skills to ensure timely completion of high-quality regulatory documents
Build/communicate credible writing/submission project timelines for the nonclinical team
Ensure and coordinate authoring, peer/management/ regulatory reviews, quality checks for accuracy
Effectively coordinate submission activities with Absorption/Distribution/Metabolism/Excretion (ADME), Toxicology (Tox)/ Pathology (Path), Pharmacokinetics (PK)/Pharmacodynamics (PD) (ATP) scientists, discovery biologists, and environmental risk assessment scientists
Anticipate and mitigate risks, to ensure document completion and delivery
Effectively communicate project status to stakeholders
Exhibit flexibility in coordinating preparation of multiple document types
Nonclinical Submissions Coordination
Establish and manage nonclinical regulatory submission timing and deliverables
Serve as the subject matter expert for nonclinical electronic Common Technical Document (eCTD) content, as well as for nonclinical document and submissions planning
Track progress, including document publishing, approval, and transition, to the regulatory submission publishing team
Knowledge Sharing and Skills Development
Maintain and enhance knowledge of regulatory guidelines
Provide guidance to others regarding any nonclinical submission/documents related information
Recognized for technical expertise in specific document development
Network with others (including other functions and regions) to identify and share best practices
Contribute to process improvements, suggesting opportunities where appropriate
Perform other duties as assigned by management
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