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Sponsor Dedicated - Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Over

$114k - $210.9k

Ladders

For our client, we are seeking a Sr. Principal Medical Writer to join the team of a leader in the Healthcare space. This remote role will support global regulatory submission efforts, with a primary focus on preparing high-quality clinical and regulatory documents for complex development programs. The position will partner closely with cross-functional teams to ensure submission materials are scientifically sound, compliant with global requirements, and delivered on schedule. In addition, this writer will help drive process consistency, mentor junior staff, and support efficient execution across multiple projects. Location: Remote Compensation: $114,000 – $210,900 annually Responsibilities Develop regulatory documents for global submission in line with ICH and client standards Manage medical writing projects, including timelines and cross-functional communication Participate in cross-functional meetings to discuss medical writing deliverables and processes Review related documents such as protocols and statistical analysis plans as needed Engage in cross-functional process improvement initiatives Define and write standard operating procedures for efficient document preparation Mentor junior medical writing staff and manage internal and contract resources Qualifications Bachelor's degree required; advanced degree preferred in a relevant scientific, clinical, or regulatory field Minimum of 5 years of medical writing experience in the biopharmaceutical or CRO industry, or comparable clinical/preclinical development experience Proficient in organizing and communicating clinical information with minimal oversight Strong organizational, time management, and project management skills Excellent verbal, written, and interpersonal communication skills for effective teamwork Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development is desired Proficient in MS Word and experienced with electronic document management systems Benefits Company car or car allowance Comprehensive health benefits including medical, dental, and vision 401k with company match Eligibility for Employee Stock Purchase Plan Potential for commissions or bonuses based on performance Flexible paid time off (PTO) and sick time Our client is an equal opportunity employer. #J-18808-Ljbffr Ladders

Vacancy posted 2 days ago
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