Principal Medical Writer / Sr Principal medical Writer- Sponsor-dedicated

Description

Principal Medical Writer / Sr Principal medical Writer- Sponsor-dedicated

Job Responsibilities

Responsibilities:

Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.

• 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.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives.
• Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections.
• Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.
• Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications:

• At least 6 years of relevant experience in science, technical, or medical writing.
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry required.
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices required.
• Extensive experience writing relevant document types required.
• Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Job Description Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. •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. •Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained. •Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. •Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained. •Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. •Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities. •Performs online clinical literature searches and complies with copyright requirements. •Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities. •Mentors and leads less experienced medical writers on complex documents. •Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives. •Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections. •Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables. •Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects. •Completes required administrative tasks within the specified timeframes. •Performs other work-related duties as assigned. •Minimal travel may be required (less than 25%).