Medical writer

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; 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.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Coordinates quality and editorial reviews.
• Ensures source documentation is managed appropriately.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.

Medical Writer II – Publications

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including developing timelines
• Participate in cross-functional meetings to provide input regarding medical writing deliverables
• Review other documents associated with the assigned project(s)

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures
• Coordinates quality and editorial reviews
• Ensures source documentation is managed appropriately
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
• Provides feedback to further define statistical output required and document needs
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary
• Performs online clinical literature searches and complies with copyright requirements
• Identifies and proposes solutions to resolve issues, escalating as appropriate
• Provides technical support, training, and consultation to department and other company staff
• Mentors and leads less experienced medical writers on complex projects, as necessary

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Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

Medical Writer II – Publications

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

Principal Medical Writer – Publications