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:
* 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.
* Ensure the accuracy, clarity, and compliance of all documents with regulatory guidelines and company standards.
* Collaborate closely with clinical, regulatory, and project teams to gather required information and ensure the timely delivery of documentation.
* Contribute to document review and approval processes, ensuring high-quality output and adherence to timelines.
* Actively participate in team meetings, offering solutions and insights to improve processes and outcomes.
...