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

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

📋 Description

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

• Comply with study/project timelines and corporate goals.

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

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

• Evaluate related project documents such as protocols and statistical analysis plans.

• Contribute to cross-functional process improvement efforts.

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

• Manage both internal and contract medical writing resources as necessary.

• Mentor junior medical writing staff.

⛳️ Requirements

• Experience in oncology is preferred, though 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 medical writing experience in the biopharmaceutical or CRO industry, or similar experience in clinical or preclinical development.

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

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

• Strong verbal, written, and interpersonal communication skills.

• In-depth 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.

• Equivalent experience, skills, and/or education will also be taken into consideration.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive organizational culture.

• Reasonable accommodations provided when appropriate.