Senior Medical Writer – Principal, Regulatory Documents

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

📋 Description

• Oversee the accurate and timely completion of medical writing deliverables.

• Manage medical writing tasks for individual studies and coordinate efforts across various departments.

• Lead the resolution of client feedback.

• Prepare clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.

• Comply with regulatory standards, company procedures, client expectations, approved templates, authorship guidelines, and style manuals.

• Organize quality control and editorial reviews.

• Appropriately manage source documentation.

• Facilitate team document reviews and serve as a peer reviewer.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings.

• Collaborate with clients and teams from data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches while adhering to copyright regulations.

• Identify issues and suggest solutions, escalating as necessary.

• Provide technical support, training, and consultation services.

• Contribute to internal materials, presentations, processes, standard practices, and capabilities.

• Mentor and guide less experienced medical writers on complex projects.

• Develop in-depth knowledge of industry topics and regulatory requirements.

• Monitor project budgets and relay status updates and changes to medical writing leadership.

• Execute administrative tasks and fulfill other assigned responsibilities.

⛳️ Requirements

• Proven experience and expertise in medical writing and regulatory documentation.

• Capability to lead the precise and timely completion of medical writing deliverables.

• Skill in managing medical writing activities for individual studies with minimal oversight.

• Familiarity with regulatory standards, including ICH E3 guidelines.

• Proficiency in working with company/client standard operating procedures, templates, authorship requirements, and style and formatting guidelines.

• Ability to coordinate quality and editorial reviews effectively.

• Competence in reviewing statistical analysis plans and specifications for tables, figures, and listings.

• Strong interaction skills with clients and cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.

• Ability to conduct online clinical literature searches in compliance with copyright regulations.

• Capability to provide technical support, training, and consultation services.

• Experience in mentoring and leading less experienced medical writers on complex projects.

• Knowledge of current industry topics and regulatory guidelines influencing medical writing.

• Ability to work within budgeted hours and complete administrative tasks in a timely manner.

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

• Occasional travel may be required (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and active line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, scientific knowledge, and sharing opportunities.

• Pathways for career progression and employment opportunities.

• Reasonable accommodations, when applicable, for applicants and employees with disabilities.