Senior Medical Writer

The Senior Medical Writer will be responsible for authoring and managing clinical regulatory documents in support of the company’s clinical development program and objectives. Reporting to the Director, Medical Writing Operations, the Senior Medical Writer’s will efficiently prepare high-quality, consistent, and accurate deliverables across the company’s development portfolio. Key Responsibilities Author and provide support for medical writing content, including but not limited to study level documents (clinical protocols and amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules and summary documents, and other writing as necessary. Collaborate closely with relevant functions, including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management teams. Partner with internal and external writers, as necessary, in support of document completion. Oversee document preparation from start to finish, including kick-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing quality control and quality assurance findings, and providing a final version within document timelines. Ensure clarity, consistency, and proper formatting of clinical documents across programs. Maintain compliance with GCP, ICH, eCTD, and company guidelines. Interpret complex clinical data and information. Demonstrate strategic thinking and review capabilities. Contribute to the development and improvement of SOPs, templates, and document standards. Qualifications PhD or advanced degree in a scientific or clinical discipline. 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing. Previous neuroscience experience is strongly preferred. Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines. Flexibility and comfortability with evolving priorities and targets. Understanding of drug development, biostatistics, and medical terminology; basic understanding of scientific methodology as applied to drug development. Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations. Proficiency in Microsoft Word (advanced features) and familiarity with document management and collaborative authoring platforms (e.g., Veeva Vault, Please Review). Ability to work independently and collaboratively in a dynamic, fast-paced, cross-functional environment. Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges. #J-18808-Ljbffr