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.
Qualifications:
* A minimum of 2 years’ experience in medical writing, particularly within regulatory writing.
* Proficient in writing clinical trial-related documents, including Investigator Brochures, Protocols, IMPDs/INDs, DSURs, and Clinical Study Reports.
* Strong understanding of regulatory requirements, including ICH, FDA, and EMA guidelines.
* Master’s degree in life sciences (PhD preferred).
* Excellent written and verbal communication skills, with an eye for detail and precision.
* Creative problem-solving skills with a proactive attitude.
Additional Skills:
* Ability to work independently and manage multiple tasks in a fast-paced environment.
* Collaborative mindset with strong interpersonal skills to interact with various teams.
* Ability to work under pressure and meet tight deadlines.
This position can be based anywhere in the UK. The candidate will be expected to attend the office in Surrey, as required, and participate in at least one team day per month.
If you are passionate about medical writing and regulatory affairs, and you're looking for a dynamic and rewarding career opportunity, we encourage you to apply.