We are seeking a detail-oriented and scientifically rigorous Medical Writer to join our Clinical Development team. This role is ideal for someone with a strong background in clinical research and a passion for quality control. You will play a pivotal role in ensuring the accuracy, consistency, and compliance of clinical trial documentation, with a particular focus on protocol development and regulatory submission deliverables.
Key Responsibilities
* Protocol Review & Development
* Collaborate with cross-functional teams to draft, review, and QC clinical trial protocols and amendments.
* Ensure protocols align with regulatory requirements, therapeutic area standards, and internal SOPs.
* Provide strategic input on study design and endpoint rationale.
* Regulatory Submission Writing
* Author and QC key regulatory documents including Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Module 2 summaries for CTD submissions.
* Support INDs, NDAs, MAAs, and other global regulatory filings with high-quality documentation.
* Maintain awareness of evolving regulatory guidance (FDA, EMA, ICH) and integrate into writing practices.
* Quality Control Activities
* Perform comprehensive QC reviews of medical writing deliverables for grammar, formatting, data consistency, and scientific accuracy.
* Develop and maintain QC checklists and style guides to standardize document review processes.
* Train and mentor junior writers on QC best practices and document standards.
* Cross-Functional Collaboration
* Liaise with Clinical Operations, Biostatistics, Regulatory Affairs, and Safety teams to ensure alignment and accuracy of source data.
* Participate in internal and external audits to support document compliance and inspection readiness.
Qualifications & Experience
* Advanced degree in life sciences (PhD, PharmD, MD, or MSc preferred).
* Medical writing experience in clinical trials and regulatory submissions.
* Strong understanding of GCP, ICH guidelines, and global regulatory frameworks.
* Exceptional attention to detail and proven QC experience.
* Proficiency in document management systems and authoring tools (e.g., MS Word, EndNote, Adobe Acrobat).