Sponsor Dedicated Principal Medical Writer Ii
hace 2 semanas
We are seeking a skilled Senior Medical Writer to join our Oncology Medical Writing Team. The successful candidate will be responsible for the development of clinical documents for submissions to regulatory authorities globally.
The ideal candidate will have extensive knowledge of English grammar, a familiarity with AMA style guide, and a strong understanding of FDA and ICH regulations and guidelines. They will also possess effective presentation, proofreading, and interpersonal skills, with a team-oriented approach.
The Senior Medical Writer will work directly with multidisciplinary project team members to write scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents.
Key qualifications for the role include a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. The candidate should also have strong proficiency in Word, Excel, PowerPoint, email, and Internet, as well as a proven track record of leading the submissions process and writing strategic parts of submissions.
We offer a dynamic and collaborative work environment, with opportunities for career development and progression. If you are a highly skilled Medical Writer with a passion for Oncology and a commitment to excellence, we encourage you to apply for this exciting opportunity.
Responsibilities:
- Development of clinical documents for submissions to regulatory authorities globally
- Writing of scientifically valid, complete, and consistent documents
- Leading the submissions process and writing strategic parts of submissions
- Collaboration with multidisciplinary project team members
- Adherence to FDA and ICH regulations and guidelines
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred)
- Extensive knowledge of English grammar and AMA style guide
- Strong understanding of FDA and ICH regulations and guidelines
- Effective presentation, proofreading, and interpersonal skills
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
What We Offer:
- Dynamic and collaborative work environment
- Opportunities for career development and progression
- Competitive compensation and benefits package
- Recognition and reward for outstanding performance
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