Senior Regulatory Medical Writer

Role Overview: As a Regulatory Medical Writer-Clinical trials (RMW-CT), you will be responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) designated by leadership. Your role will involve supporting the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests. You will be the lead contact for sponsor or designated HA interactions with cross-functional teams, ensuring the accuracy and quality of submission-ready documents. Key Responsibilities: - Serve as the regulatory lead representative on project teams, partnering with outsourcing and operational teams to prepare high-quality documents such as Clinical Study Reports, Clinical Summaries, and Protocol Summaries for submission. - Understand Clinical Trial Protocol elements, coordinate review meetings, resolve document content issues independently, and prepare scientific communications for external publication. - Provide leadership and project management expertise, ensure accurate and timely completion of regulatory submissions, and communicate progress to leadership regularly. - Mentor and provide guidance to support staff, identify and implement process improvements, and assess resource needs as timelines progress. Qualifications Required: - Bachelor of Science in life sciences with significant relevant writing experience. - Advanced degree (e.g., MS Pharmacy, PharmD, PhD, MD) preferred, with a certificate in regulatory affairs and/or medical writing highly preferred. - 2-4 years of relevant industry experience in medical/regulatory writing required, with a good understanding of clinical development processes and guidelines. - High-level content writing experience, excellent written and oral communication skills, attention to detail, and peer-review/editing skills are beneficial. - Knowledge of Common Technical Document (CTD) content templates, electronic document management systems, and software programs like MS Word/PowerPoint/Excel is necessary.,