Principal Medical Writer – Regulatory Submission

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

📋 Description

• Create regulatory documentation for global submission to regulatory authorities in alignment with ICH, worldwide guidelines, standards, processes, and relevant Incyte authoring standards.

• Oversee medical writing projects, including timelines and communication with cross-functional teams regarding review cycles and expectations.

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

• Evaluate related project documents, including Protocols and Statistical Analysis Plans.

• Take part in cross-functional initiatives aimed at process improvement.

• Establish and document standard operating procedures and best practices for the efficient creation of high-quality documents.

• Supervise internal and contract medical writing resources to ensure timely project delivery.

• Provide mentorship to junior medical writing personnel.

• Show interest in being considered for a potential upcoming opportunity and talent pipeline.

⛳️ Requirements

• Proven experience in developing regulatory documents for global submissions to regulatory agencies.

• Familiarity with ICH and other international guidelines, standards, and processes.

• Capability to adhere to study/project timelines and corporate goals.

• Competence in managing medical writing projects and formulating timelines.

• Experience in communicating with members of cross-functional teams and participating in cross-functional meetings.

• Ability to assess project documents such as Protocols and Statistical Analysis Plans.

• Background in process improvement initiatives.

• Proficiency in defining and drafting standard operating procedures and best practices.

• Ability to manage both internal and contract medical writing resources effectively.

• Capacity to mentor junior medical writing staff.

• Equivalent experience, skills, and/or educational background may also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• A culture that promotes authenticity and belonging through the Total Self initiative.

• A workplace culture focused on diversity, equity, and inclusion.

• Remote work options (Remote (Pre-Approved)).