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

This is a fully remote position, open to applicants in United States.

📋 Description

• Create regulatory documents for submission to global regulatory agencies, adhering to ICH and other international guidelines, standards, and client authoring specifications.

• Oversee medical writing projects, including establishing timelines and coordinating with cross-functional team members regarding review cycles and expectations.

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

• Review project documents such as protocols and statistical analysis plans.

• Take part in initiatives aimed at improving cross-functional processes.

• Assist in defining and drafting standard operating procedures and best practices for the efficient creation of high-quality documents.

• Supervise internal and contract medical writing resources to ensure projects are completed on time.

• Provide mentorship to junior medical writing personnel.

⛳️ Requirements

• Experience in oncology is preferred, but not mandatory.

• 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 experience in medical writing within the biopharmaceutical or CRO industry is required, or equivalent experience in clinical or preclinical development.

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

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

• Excellent verbal, written, and interpersonal communication skills.

• Solid understanding of global regulatory requirements.

• Knowledge of therapeutic areas across all phases of clinical development is desirable.

• Proficient in MS Word.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive company culture.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• 401k with company match.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.