Medical Writer Lead for Clinical Studies
4 days ago
Job Title: Medical Writer Lead for Clinical Studies
Job Location: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
About UsWe are Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT. Our platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Job DescriptionWe are seeking a highly experienced Medical Writer Lead to join our team. The successful candidate will be responsible for mentoring and leading less experienced medical writers on complex projects, as well as acting as lead for assigned writing projects.
The ideal candidate will have extensive knowledge of English grammar and FDA and ICH regulations and guidelines, as well as a familiarity with AMA style guide. Strong proficiency in Word, Excel, PowerPoint, email, and Internet is also required.
Responsibilities:
- Mentor and lead less experienced medical writers on complex projects
- Act as lead for assigned writing projects
- Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
- Develop or support a variety of documents, including clinical study protocols and reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, and clinical journal manuscripts and abstracts
- Identify and propose solutions to resolve issues and questions arising during the writing process
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
- Serve as peer reviewer on internal review team providing review comments on draft and final documents
- Adhere 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 when completing medical writing projects
Qualifications:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines, as well as a familiarity with AMA style guide
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
Estimated Salary: $80,000 - $100,000 per year
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