Principal Medical Writer – Regulatory Submission

🔥 2 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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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 global submission to regulatory agencies in accordance with ICH, global guidelines, standards, processes, and applicable Incyte authoring standards • Manage medical writing projects, including timelines and communication with cross-functional teams regarding review cycles and expectations • Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes • Review associated project documents, including Protocols and Statistical Analysis Plans • Participate in cross-functional process improvement initiatives • Define and write standard operating procedures and best practices for efficient preparation of quality documents • Manage internal and contract medical writing resources to ensure timely project completion • Mentor junior medical writing staff • Express interest for consideration in a potential upcoming opportunity and talent pipeline

🎯 Requirements

• Experience developing regulatory documents for submission to regulatory agencies globally • Knowledge of ICH and other global guidelines, standards, and processes • Ability to adhere to study/project timelines and corporate objectives • Ability to manage medical writing projects and develop timelines • Experience communicating with cross-functional team members and participating in cross-functional meetings • Ability to review project documents such as Protocols and Statistical Analysis Plans • Experience with process improvement initiatives • Ability to define and write standard operating procedures and best practices • Ability to manage internal and contract medical writing resources • Ability to mentor junior medical writing staff • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and belonging • Diversity, equity, and inclusion-focused workplace culture • Remote work (Remote (Pre-Approved))