Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase
Syneos Health/ inVentiv Health Commercial LLC, Los Angeles, CA, United States
Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase
Job Responsibilities
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. Leads the resolution of comments from the client.
Completes a variety of documents that may include clinical study protocols, protocol 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, abstracts, posters, and scientific meeting presentations.
Adheres to established regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates; ensures projects are completed on time and on budget.
Coordinates quality and editorial reviews; ensures source documentation is managed appropriately; leads team document reviews and performs reviews as needed.
Acts as peer reviewer for internal team to ensure scientific content, clarity, consistency, and proper format.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency; provides feedback to define statistical output and document needs.
Interacts and builds good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
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 staff; contributes to development of internal materials and process improvements.
Mentors and leads less experienced medical writers on complex projects as needed.
Develops deep expertise in key industry topics and regulatory requirements affecting medical writing.
Aware of budget specifications for projects, works within budgeted hours and communicates status and changes to leadership.
Completes required administrative tasks within specified timeframes.
Performs other work‑related duties as assigned.
Minimal travel may be required (less than 25%).
Benefits
Benefits may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility for Employee Stock Purchase Plan, commission/bonus potential, and flexible paid time off & sick time.
Salary Range: $80,600.00 - $145,000.00
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. The Company will determine what constitutes equivalent to the qualifications described. Nothing herein should be construed to create an employment contract.
All obligations comply with the legislation of each country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, and will provide reasonable accommodations as appropriate.
#J-18808-Ljbffr
Job Responsibilities
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. Leads the resolution of comments from the client.
Completes a variety of documents that may include clinical study protocols, protocol 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, abstracts, posters, and scientific meeting presentations.
Adheres to established regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates; ensures projects are completed on time and on budget.
Coordinates quality and editorial reviews; ensures source documentation is managed appropriately; leads team document reviews and performs reviews as needed.
Acts as peer reviewer for internal team to ensure scientific content, clarity, consistency, and proper format.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency; provides feedback to define statistical output and document needs.
Interacts and builds good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
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 staff; contributes to development of internal materials and process improvements.
Mentors and leads less experienced medical writers on complex projects as needed.
Develops deep expertise in key industry topics and regulatory requirements affecting medical writing.
Aware of budget specifications for projects, works within budgeted hours and communicates status and changes to leadership.
Completes required administrative tasks within specified timeframes.
Performs other work‑related duties as assigned.
Minimal travel may be required (less than 25%).
Benefits
Benefits may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility for Employee Stock Purchase Plan, commission/bonus potential, and flexible paid time off & sick time.
Salary Range: $80,600.00 - $145,000.00
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. The Company will determine what constitutes equivalent to the qualifications described. Nothing herein should be construed to create an employment contract.
All obligations comply with the legislation of each country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, and will provide reasonable accommodations as appropriate.
#J-18808-Ljbffr