The Principal Medical Writer is responsible for providing scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. The Prinicipal Medical Writer provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. The Prinicipal Medical Writer serves as a scientific writing content expert for the department and actively contributes to process improvement activities.

Responsibilities

• Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents.
• Serves as a department representative on project teams. Serves as a subject matter expert within department for assigned therapeutic/product areas. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. COSMOS, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers. Implements tactical process improvements.
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is completed.
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively.
• Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards.
• Responsible for effective communication to team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
• Understands, assimilates, and interprets sources of info Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
• Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. 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.
• Recommends and implements tactical process improvements. Participates in process improvement activities.