Sponsor Dedicated Protocol Medical Writer II/Sr

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Collaborate closely with Clinical Scientists on study protocols and amendments.

• Lead the creation of precise and effective medical writing deliverables.

• Oversee medical writing tasks for individual studies with limited supervision.

• Coordinate medical writing efforts both within and across various departments.

• Manage the resolution of client feedback.

• Produce clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consent documents, 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 ICH E3 guidelines, regulatory standards, SOPs, client expectations, approved templates, authorship requirements, and style guides.

• Organize quality and editorial reviews and oversee source documentation management.

• Lead document reviews within the team and serve as a peer reviewer.

• Evaluate statistical analysis plans and table/figure/listing specifications.

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

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

• Identify issues and suggest solutions, escalating them when necessary.

• Offer technical support, training, and consultation as needed.

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

• Mentor and guide junior medical writers on intricate projects.

• Cultivate expertise in industry topics and regulatory demands.

• Track project budgets and communicate updates and changes to medical writing leadership.

• Fulfill administrative duties and other assigned responsibilities.

⛳️ Requirements

• 3-5 years of pertinent experience in scientific, technical, or medical writing.

• Required experience in the biopharmaceutical, medical device, or contract research organization sectors.

• Familiarity with late-stage development and Oncology/Hematology/Cell therapy/Neurology.

• Strong knowledge of FDA and ICH regulations, other regulatory guidelines, and good publication practices is essential.

• Required experience in writing pertinent document types.

• Experience with Veeva/CARA is preferred.

• Extensive understanding of English grammar with the ability to communicate effectively.

• Strong familiarity with the AMA Manual of Style.

• Capability to work remotely from Portugal, Spain, the UK, Poland, or Canada.

• Occasional 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.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Limited travel requirements (less than 25%).