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

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Create regulatory documents for submission to global regulatory bodies, ensuring compliance with ICH and other international guidelines, standards, processes, and client-specific authoring standards.

• Follow study/project timelines and meet corporate objectives.

• Oversee medical writing projects, which includes developing timelines and liaising with cross-functional team members regarding review cycles and expectations.

• Engage in cross-functional meetings, offering insights on medical writing deliverables, timelines, and processes.

• Review documents related to assigned projects, such as protocols and statistical analysis plans.

• Take part in cross-functional process enhancement initiatives.

• Assist in defining and drafting 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.

• Provide mentorship to junior medical writing personnel.

⛳️ Requirements

• Oncology experience preferred, though not mandatory.

• A Bachelor's degree is required.

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

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

• Ability to organize and communicate clinical information effectively with minimal supervision.

• Excellent organizational, time management, and project management abilities.

• Strong verbal, written, and interpersonal communication skills.

• Solid understanding of global regulatory requirements.

• Familiarity with therapeutic areas across all stages of clinical development is desired.

• Proficient in MS Word.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company car or car allowance.

• Medical, dental, and vision benefits.

• 401k with company matching.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.