Tech Writer - IND , GMP
Edison-New Brunswick Metro Area, NJ
- MS Degree with 2 - 5 years of experience in Technical writing of reports for cGMP for Non clinical pharmaceutical development activities
Excellent technical writing and verbal communication skills required.
Must have experience with Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for Food and Drug Administration (FDA) submissions, and nonclinical & regulatory documents with registration dossiers for worldwide use.
- Knowledge of FDA and ICH guidelines.
- Ability to work with multiple complex projects and within cross-functional teams.
- Writing Stability, Methods, Validation reports, specification Justification documents and other technical reports for IND, NDA, and CTD applications to Health Authorities.
- Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
- Working with other relevant line functions to prepare/review regulatory documents and submissions,
- Follow internal guidelines for document preparation.
- Follow templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
- Participate in study and project team meetings and assist the teams in resolving issues related to document preparation.
- Attend Product Development Team meetings and Department Group Meetings to become informed in upcoming needs for nonclinical writing.
- Implement the strategy for document preparation and NCD review that includes time frames that meet or exceed company standards and the document review processes.
- . Facilitate document review and approval.
- . Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence