Outpace Consulting Services is seeking a Regulatory Medical Writer with expertise in Life Sciences for a leading ITES company. In this role, you'll be responsible for developing clear, accurate, and well-structured medical and scientific documents specifically tailored for regulatory authorities. This involves translating complex clinical and scientific data into compliant and understandable content for various regulatory submissions and clinical trial documentation. You'll collaborate closely with researchers and regulatory teams, ensuring all information is scientifically sound, adheres to industry guidelines, and meets the needs of the target audience.
Key Responsibilities:
- Regulatory Document Preparation: Prepare and review a wide range of clinical documents for regulatory submissions, including but not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post-Approval Documents, Clinical Summary of Safety, Clinical Summary of Efficacy, and Common Technical Document (CTD) Modules across various Therapeutic Areas.
- Quality Assurance & Compliance: Conduct thorough quality checks on all clinical documents, ensuring high standards for scientific content, organization, clarity, accuracy, format, and consistency, while strictly adhering to regulatory guidelines, Standard Operating Procedures (SOPs), Document Standards, and Guidance documents.
- Team Collaboration & Coordination: Initiate start-up meetings with Study Teams, and work closely with all internal and external study team members throughout the document development process. Effectively share project timelines to ensure smooth coordination.
- Data Integration & Review: Review statistical analysis plans and table/figure/listing as needed, ensuring uniformity and consistency in the scientific content of all regulatory documents.
- Timely Delivery & Project Support: Prepare medical writing documents within established timelines, ensuring high quality. Actively plan content, format, and timing of documents, manage report scheduling/tracking, and support assigned clinical development or project teams to meet project needs and department standards.
- Quality Control & Peer Review: Perform peer review and quality control review of documents within established timelines, adhering to applicable guidelines and processes using appropriate checklists.
- Meeting Management: Plan and organize project and non-project meetings as required.
Required Qualifications:
- Experience:Minimum 1 year of experience with regulatory submission formats such as eCTD / NEES / Docubridge.
- Proven experience in making Clinical Study Reports and Clinical Summary of Safety.
- Education: Any Life Science Graduate.
- Skills: Strong writing skills, exceptional attention to detail, and a solid understanding of medical terminology and research practices.
To Apply: WhatsApp Hi to +91 9151555419. Then, follow these steps:
- Click on Start to Apply and fill in your details.
- Select the location as Other (to get multiple location options).
- For Mumbai, type: Job Code #56
- For Pune, type: Job Code #57
