The candidate will manage critical documentation processes, ensure compliance with Good Documentation Practices (GDP), and support quality assurance activities related to SOPs, batch records, forms, and regulatory requirements. Create, format, and edit Standard Operating Procedures (SOPs), batch records, and other forms according to company standards and regulatory requirements. Manage the EDMS, ensuring the timely routing, review, and approval of documents. Ensure controlled documents are appropriately organized, maintained, and accessible. Enforce GDP across all documentation-related activities to maintain data integrity, clarity, and accuracy in all official records. Assist in creating and organizing training materials and records, including tracking training completions and retraining needs for personnel.

Provides expert-level technical writing in assigned area/s. Coordinates multi-disciplinary teams and external personnel to compile information and collaborate effectively. Prepares reports, reviews grant proposals, and coordinates development of scientific materials to support outreach and donor cultivation efforts. Prepares manuscripts, presentations, regulatory materials, and other communications.

Provides expert-level technical writing in assigned area/s. Coordinates multi-disciplinary teams and external personnel to compile information and collaborate effectively. Prepares reports, reviews grant proposals, and coordinates development of scientific materials to support outreach and donor cultivation efforts. Prepares manuscripts, presentations, regulatory materials, and other communications.

The candidate will manage critical documentation processes, ensure compliance with Good Documentation Practices (GDP), and support quality assurance activities related to SOPs, batch records, forms, and regulatory requirements. Create, format, and edit Standard Operating Procedures (SOPs), batch records, and other forms according to company standards and regulatory requirements. Manage the EDMS, ensuring the timely routing, review, and approval of documents. Ensure controlled documents are appropriately organized, maintained, and accessible. Enforce GDP across all documentation-related activities to maintain data integrity, clarity, and accuracy in all official records. Assist in creating and organizing training materials and records, including tracking training completions and retraining needs for personnel.