Sponsor Dedicated - Senior Medical Writer (Regulatory Documents - CSR, Protocols, IB) - North America or EMEA

Overview

Senior Medical Writer supporting sponsor-dedicated regulatory documents (CSR, protocols, IB) for North America or EMEA.

What you'll do

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities for individual studies, coordinating within and across departments with minimal supervision.
• Lead the resolution of comments from the client.
• Complete documents that may include clinical study protocols and 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; and abstracts, posters and presentations for scientific meetings.
• Adhere to regulatory standards including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides, on time and on budget.
• Coordinate quality and editorial reviews and ensure source documentation is managed appropriately.
• Lead team document reviews and act as peer reviewer for scientific content, clarity, consistency and format.
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format and consistency, and provide feedback on statistical output and document needs.
• Interact and build working relations with clients, department heads and peers in data management, biostatistics, regulatory affairs and medical affairs.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to issues, escalating as appropriate.
• Provide technical support, training and consultation to department and other company staff.
• Contribute to internal materials, presentations, and process or standard practice changes as needed.
• Mentor and lead less experienced medical writers on complex projects as necessary.
• Develop deep expertise on key industry topics and the regulatory requirements and guidelines affecting medical writing.
• Work within budgeted hours for assigned projects and communicate status and changes to medical writing leadership.
• Complete required administrative tasks within specified timeframes.
• Perform other work-related duties as assigned.

What you'll need

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry (required).
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices (strongly required).
• Experience writing relevant document types (required).
• Extensive knowledge of English grammar and ability to communicate clearly.
• Strong familiarity with AMA Manual of Style.

Details

• Location: USA, Remote.
• Minimal travel may be required (less than 25%).
• Salary range: $80,600.00 - $175,700.00 (actual salary varies by qualifications, skills, competencies and proficiency).
• Benefits may include a company car or car allowance, Medical/Dental/Vision, 401k company match, Employee Stock Purchase Plan eligibility, commission/bonus eligibility, and flexible PTO and sick time.