Senior Medical Writer – Regulatory Focus

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

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

• Direct medical writing tasks related to individual studies and synchronize efforts across various departments.

• Facilitate the resolution of client feedback.

• Generate clinical study protocols, protocol amendments, clinical study 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.

• Adhere to ICH E3 guidelines, company standard operating procedures, client specifications, approved templates, authorship requirements, and style and formatting guides.

• Manage quality and editorial reviews and oversee source documentation.

• Lead team document evaluations and review documents as necessary.

• Serve as a peer reviewer for internal teams.

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

• Collaborate with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches while ensuring compliance with copyright regulations.

• Identify and suggest solutions, escalating issues as needed.

• Provide technical support, training, and guidance.

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

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

• Develop expertise in industry-related topics and regulatory requirements impacting medical writing.

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

• Complete necessary administrative tasks.

• Perform other assigned work-related responsibilities.

• Some travel may be required, accounting for less than 25% of the role.

⛳️ Requirements

• A minimum of 5 years of experience in lead regulatory writing.

• Experience as a lead writer for Phase 2 and Phase 3 studies.

• Proficiency as a lead writer for protocols.

• Experience as a lead writer for submissions.

• Experience as a lead writer for Clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4.

• Experience as a lead writer for Clinical Study Reports (CSRs).

• Experience as a lead writer for Investigator Brochures (IBs).

• Experience as a lead writer for Patient Narratives.

• Experience with Safety Aggregate Reports is advantageous.

• Experience as a lead writer for Briefing Books.

• Experience as a lead writer for Integrated Summary Efficacy (ISE) and Integrated Summary Safety (ISS).

• Strong skills in project management.

• Excellent client relationship skills.

• Proficient time management skills.

• Experience in process management is a plus.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Comprehensive technical and therapeutic area training.

• Peer recognition and a total rewards program.

• An inclusive workplace culture.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations when necessary.