•Serves as medical writing lead on clinical regulatory documents. Works closely with the Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
•Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
•Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s) or clinical regulatory requirements.
•Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
•Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies.
•Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
•Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
•Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
•Knowledgeable of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards.
•Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. COSMOS, ARCH, eCTD). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.