Sponsor Dedicated Medical Writer II/Sr

This is a fully remote position, open to applicants in Portugal, +4 more states.

📋 Description

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

• Manage medical writing tasks related to specific studies.

• Facilitate medical writing efforts within and between departments with little oversight.

• Drive the resolution of client feedback.

• Prepare clinical, regulatory, safety, publication, and submission documents.

• Comply with regulatory standards, ICH E3 guidelines, company SOPs, client expectations, templates, authorship criteria, and style guides.

• Organize quality and editorial evaluations.

• Appropriately manage source documentation.

• Lead team document assessments and serve as a peer reviewer.

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

• Engage with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.

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

• Recognize and suggest solutions to address issues.

• Offer technical support, training, and consultation services.

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

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

• Develop knowledge in industry topics and regulatory requirements.

• Operate within budgeted hours and relay status updates and changes to medical writing leadership.

• Complete necessary administrative tasks and other assigned responsibilities.

⛳️ Requirements

• 3–5 years of pertinent experience in science, technical, or medical writing.

• Experience in the biopharmaceutical, medical device, or contract research organization sector is essential.

• Solid understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.

• Experience in writing relevant document types.

• Extensive knowledge of English grammar.

• Ability to communicate effectively.

• Strong familiarity with the AMA Manual of Style.

• Capability to work within budgeted hours and specified deadlines.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition and a total rewards program.

• An inclusive culture.

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

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

• Various career paths and employment opportunities.

• Collaborate with dedicated problem solvers.

• Partner with a diverse team of experts in the industry.