Senior Medical Writer – Regulatory

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

📋 Description

• Oversee medical writing responsibilities related to specific studies, facilitating coordination of medical writing tasks within and between departments with minimal oversight.

• Fulfill necessary administrative duties within designated timeframes.

• Conduct online searches of clinical literature and ensure compliance with copyright regulations.

• Acquire in-depth knowledge on critical industry topics as well as the regulatory standards and guidelines impacting medical writing.

• Some travel may be necessary (under 25%).

⛳️ Requirements

• Direct the precise and clear production of medical writing outputs, guaranteeing that scientific information is conveyed accurately and understandably.

• Prepare a range of documents which may encompass clinical study protocols and their 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; as well as abstracts, posters, and presentations for scientific conferences.

• Comply with established regulatory norms, including but not limited to ICH E3 guidelines, along with company standard operating procedures, client standards, and approved templates, authorship criteria, and style and formatting guidelines, ensuring timely and budget-conscious completion of medical writing tasks.

• Manage quality and editorial assessments.

• Serve as a peer reviewer for the internal team to verify the scientific content, clarity, consistency, and correct formatting of documents.

• Evaluate statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, formatting, and consistency.

• Engage and foster positive working relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs, as needed, to deliver writing outputs.

• Recognize and suggest solutions to address issues.

• Mentor and guide junior medical writers on complex assignments, as needed.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k.

• Opportunity to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO) and sick leave.