Principal Medical Writer

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

📋 Description

• Conduct research, develop, write, and edit high-quality clinical and regulatory documents.

• Oversee intricate medical writing projects, ensuring scientific accuracy, adherence to regulatory standards, and timely delivery.

• Create Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Informed Consent Forms (ICFs).

• Act as the lead medical writer, submission coordinator, and primary point of contact for clients as necessary.

• Facilitate contributions from various writers and cross-functional stakeholders.

• Manage project priorities, timelines, and deliverables while upholding high-quality standards.

• Establish trusted relationships with clients and internal partners.

• Collaborate with stakeholders to ensure alignment of expectations, resources, and project goals.

• Offer medical writing expertise to assist with proposals and new business initiatives.

• Mentor, train, and share insights with colleagues.

• Identify opportunities to enhance medical writing processes, efficiency, and quality.

• Contribute to collaboration, continuous learning, and innovation within the Medical Writing organization.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, or a related field, or equivalent qualifications.

• Strong grasp of clinical research, drug development, and relevant regulatory guidelines.

• Extensive experience in preparing clinical and regulatory documentation, particularly CSRs, IBs, and ICFs.

• Proven experience in managing complex medical writing projects.

• Knowledge of resource planning and productivity management.

• Advanced proficiency in Microsoft Word.

• Familiarity with document management systems, SharePoint, Excel, and related technologies.

• Fluency in both written and spoken English.

• Exceptional written, verbal, interpersonal, and negotiation skills.

• Ability to operate effectively in a global, matrixed environment with diverse teams and stakeholders.

• Strong attention to detail and capability to balance multiple projects and competing priorities.

🏝️ Benefits

• Fully remote work from Canada.

• Opportunity to contribute to clinical research that aids in delivering innovative treatments to patients globally.

• Lead intricate medical writing projects and play a pivotal role in regulatory documentation and submissions.

• Collaborate with skilled medical writers, cross-functional teams, and clients throughout the life sciences sector.

• Mentor colleagues and support continuous improvement.

• Engage in meaningful global clinical development initiatives.