Senior Medical Content Specialist
3 weeks ago
We are seeking a highly skilled Senior Medical Writer to join our team at Lifelancer. As a key member of our medical writing team, you will be responsible for creating high-quality clinical documents, including clinical study protocols, clinical study reports, and regulatory submissions.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, ensuring timely delivery and high-quality output.
- Act as lead for assigned writing projects, coordinating medical writing activities within and across departments with minimal supervision.
- Develop and manage medical writing activities associated with individual studies, coordinating with data management, biostatistics, regulatory affairs, and medical affairs teams as necessary.
- Collaborate with cross-functional teams to develop and implement clinical development plans, IND submissions, and annual reports.
- Review and revise clinical study protocols, clinical study reports, and other clinical documents to ensure accuracy, completeness, and regulatory compliance.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Stay up-to-date with current industry practices and regulatory requirements and guidelines that affect medical writing, ensuring that all documents meet the highest standards of quality and regulatory compliance.
- 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 and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
We offer a dynamic and supportive work environment, opportunities for career growth and development, and a competitive compensation package. If you are a motivated and detail-oriented medical writer with a passion for creating high-quality clinical documents, we encourage you to apply for this exciting opportunity.
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