Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Create regulatory documents for global submission to regulatory bodies, adhering to ICH and other international guidelines, standards, and processes, as well as client-specific authoring standards, while aligning with study/project timelines and corporate goals.

• Oversee medical writing projects, which includes developing timelines in collaboration with study/project teams and maintaining communication with cross-functional team members to ensure awareness of review cycles and expectations.

• Engage in cross-functional meetings to offer insights on medical writing deliverables, timelines, and any necessary processes for the successful completion of regulatory documents.

• Evaluate other documents related to assigned projects (e.g., Protocols and Statistical Analysis Plans) as deemed appropriate.

• Involve in cross-functional initiatives aimed at process improvement.

• Contribute to the development and writing of standard operating procedures and best practices to ensure the efficient preparation of high-quality documents.

• Manage both internal and contract medical writing resources as needed to guarantee the timely completion of assigned projects.

• Provide mentorship to junior medical writing staff.

⛳️ Requirements

• A Bachelor's degree is required.

• An advanced degree in a relevant scientific, clinical, or regulatory field is preferred.

• A minimum of 5 years of medical writing experience within the biopharmaceutical/CRO industry is required, or equivalent experience in clinical or preclinical development.

• Demonstrated ability to organize and communicate clinical information with minimal oversight is essential.

• Strong organizational, time management, and project management skills are required.

• Excellent verbal, written, and interpersonal communication skills are crucial for effective teamwork.

• A solid understanding of global regulatory requirements is necessary, along with knowledge of therapeutic areas across all phases of clinical development.

• Proficient in MS Word.

• Experience with electronic document management systems and templates is required.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision.

• Company match 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.

• Company car or car allowance.