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

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

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

• Ensure compliance with study/project timelines and corporate goals.

• Oversee medical writing projects by 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, including protocols and statistical analysis plans.

• Contribute to cross-functional initiatives aimed at process improvement.

• Develop and document standard operating procedures and best practices to facilitate the efficient preparation of high-quality documents.

• Manage both internal and contract medical writing teams to ensure timely completion of projects.

• Provide mentorship to junior medical writing personnel.

⛳️ Requirements

• 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 equivalent experience in clinical or preclinical development.

• Ability to organize and convey clinical information with little oversight.

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

• Strong verbal, written, and interpersonal communication skills.

• Comprehensive understanding and knowledge of global regulatory requirements.

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

• Proficiency in MS Word.

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

• Oncology experience is preferred but not mandatory.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical training and therapeutic area education.

• Peer recognition and a total rewards program.

• An inclusive company culture.

• Company car or car allowance.

• Comprehensive medical, dental, and vision health benefits.

• Company-matched 401(k) plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.