Description
We are seeking a Principal Medical Writer to develop clinical documents for submissions to regulatory authorities globally. As a senior medical writer, you will provide strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.
Key Responsibilities:
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client's authoring standards
- Manage medical writing projects, including developing timelines and communication with cross-functional team members
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents
- Review other documents associated with the assigned project(s), as appropriate
- Participate in cross-functional process improvement initiatives
- Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
Requirements:
- Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development
- Proficiency in organizing and communicating clinical information required with minimal oversight
- Strong organizational, time management, and project management skills are required
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
- Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired