Job Description
We are seeking a motivated and experienced Regulatory Medical Writer to join our clients dynamic team. The company values innovation, creativity, and collaboration to improve patient outcomes.
As a Regulatory Medical Writer, you will be responsible for creating and managing high-quality regulatory documents to support the development of pharmaceuticals and medical devices. The ideal candidate will have a solid background in regulatory writing with a focus on clinical trials and submissions. You will collaborate with various internal teams to ensure compliance with regulatory requirements and contribute to the successful development of new treatments.
Key Responsibilities:
1. Develop and write key regulatory documents, including but not limited to Investigator Brochures, Protocols, ILAP applications, CTD submissions, IMPD/INDs, DSURs, Clinical Study Reports, TDPs, and NDAs.
2. Ensure the accuracy, clarity, and compliance of all documents with regulatory guidelines and company standards.
3. Collaborate closely with clinical, regulatory, and project teams to gather required information and ensure the timely delivery of documentation.
4. Contribute to document review and approval processes, ensuring high-quality output and adherence to timelines.
5. Actively participate in team meetings, offering solutions and insights to improve processes and outcomes...