Senior Medical Writer – Regulatory Documents

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

📋 Description

• Oversee the precise and effective completion of medical writing deliverables.

• Coordinate medical writing tasks related to specific studies and liaise across various departments.

• Lead the resolution of feedback from clients.

• Prepare clinical and regulatory documents such as protocols, clinical study reports, patient narratives, investigator brochures, informed consents, safety reports, clinical development plans, IND submissions, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.

• Implement regulatory standards, company procedures, client expectations, templates, authorship guidelines, and style manuals.

• Organize quality and editorial reviews.

• Appropriately manage source documentation.

• Facilitate team document reviews and conduct peer evaluations.

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

• Collaborate with clients as well as the data management, biostatistics, regulatory affairs, and medical affairs teams.

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

• Identify and suggest solutions to challenges, escalating issues when necessary.

• Offer technical support, training, and consultation.

• Contribute to the development of internal materials, presentations, processes, standards, and capabilities.

• Mentor and guide junior medical writers through complex projects.

• Cultivate expertise in regulatory requirements and industry topics relevant to medical writing.

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

• Complete administrative responsibilities and any other assigned tasks.

⛳️ Requirements

• Leads medical writing deliverables ensuring clear and precise scientific content.

• Capable of managing medical writing activities across individual studies and departments with minimal oversight.

• Familiarity with regulatory standards, including ICH E3 guidelines.

• Proficient in working with company and client SOPs, standards, templates, authorship criteria, and style guides.

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

• Skilled in conducting online clinical literature searches while adhering to copyright norms.

• Ability to collaborate effectively with clients and cross-functional teams.

• Competence in providing technical support, training, and consultation.

• Capability to mentor and lead junior medical writers on intricate projects.

• Proficient in managing project budgets and communicating updates and changes.

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

• Some travel may be necessary (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

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

• Some travel may be necessary (less than 25%).