Medical Writer / USA

Purpose:
Responsible for providing writing support to clinical trial results disclosure public postings of clinical trial data/information and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. Ensures successful preparation of high-quality postings and effective implementation of the clinical writing process.

Responsibilities:
* Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
* Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
* Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
* Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
* Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results disclosure public postings.
* Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
* Identifies conflicts and resolves or elevates them to management to ensure resolution.
* 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.).
* Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
* Continually trains/is compliant with all current industry requirements as they relate to clinical trial disclosure and various regulated agencies.