Job Description
At Astrix, we're expanding our team to support a diverse range of clients across various industries. We're seeking talented Clinical Medical Writers to join us! Our partners range from emerging biotech firms to established pharmaceutical companies, all seeking professionals who can craft high-quality regulatory and clinical documents that support global submissions and advance innovative therapies through the development pipeline! Opportunities are available both remotely and on-site throughout the country.
Responsibilities: - Prepare high-quality clinical documents including:
- Clinical Study Protocols and Protocol Amendments
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Informed Consent Forms (ICFs)
- Clinical sections of regulatory submission dossiers (e.g., IND, NDA, BLA, MAA)
- Briefing documents and regulatory responses
- Ensure documents comply with relevant regulatory guidelines (ICH, FDA, EMA) and company standards.
- Interpret clinical data and translate complex information into clear, concise, and scientifically accurate documents.
- Work cross-functionally with clinical teams, statisticians, regulatory affairs, and subject matter experts to ensure document accuracy and consistency.
- Maintain version control, manage timelines, and support document review processes, including resolving reviewer comments.
- Contribute to document planning, content development strategies, and template creation or refinement.
- Stay up to date with clinical and regulatory developments relevant to medical writing.
Qualifications: - Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (PhD, PharmD, MS, or MD) preferred.
- Minimum of 3 years of experience in clinical medical writing.
- Comfortable with electronic Common Technical Document (eCTD) format and regulatory submission standards.
- Experience working on documents for various phases of clinical trials (Phase I–IV).
- Working knowledge of statistical concepts used in clinical data reporting.
- Experience with document management systems (e.g., Veeva Vault, SharePoint).
- Strong understanding of clinical development processes, trial design, and regulatory documentation requirements.
- This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
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