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

🔥 1 hour ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Develop regulatory documents for submission to regulatory agencies globally, following ICH and other global guidelines, standards, processes, and client authoring standards • Adhere to study/project timelines and corporate objectives • Manage medical writing projects, including developing timelines and communicating with cross-functional team members about review cycles and expectations • Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes • Review associated project documents such as protocols and statistical analysis plans • Participate in cross-functional process improvement initiatives • Help define and write standard operating procedures and best practices for efficient preparation of quality documents • Manage internal and contract medical writing resources as required • Mentor more junior medical writing staff

🎯 Requirements

• Oncology experience preferred, but not required • Bachelor's degree required • Advanced degree in a relevant scientific/clinical/regulatory field preferred • At least 5 years of medical writing experience in the biopharmaceutical/CRO industry, or comparable experience within clinical or preclinical development • Proficiency in organizing and communicating clinical information with minimal oversight • Strong organizational, time management, and project management skills • Strong verbal, written, and interpersonal communication skills • Proficient understanding and knowledge of global regulatory requirements • Knowledge of therapeutic areas in all phases of clinical development desired • Proficient in MS Word • Experience with an electronic document management system and templates required • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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