Job Description

We are seeking an Associate Medical Writer to support the preparation, review, and development of high-quality clinical and medical writing deliverables for pharmaceutical, biotechnology, and clinical research programs. The Associate Medical Writer will work closely with Senior Medical Writers, Clinical Operations, Biostatistics, Data Management, Medical Affairs, and Regulatory Affairs teams to develop scientifically accurate, clear, consistent, and regulatory-compliant documents. This is an excellent opportunity for an early-career medical writer looking to build experience in clinical development and regulatory medical writing. Key Responsibilities Assist in the preparation, writing, editing, and review of clinical and medical documents. Clinical Study Reports (CSRs) Clinical study protocols and amendments Investigator's Brochures (IBs) Safety reports and summaries Clinical summaries Submission-related documents Study-related presentations and other clinical documents Review and incorporate comments from clinical, statistical, safety, regulatory, and other cross-functional stakeholders. Conduct literature searches and review scientific/medical literature as required. Assist in interpreting and summarizing clinical and statistical information under appropriate guidance. Perform document QC for accuracy, consistency, formatting, references, abbreviations, and adherence to templates. Ensure documents follow applicable FDA, ICH-GCP, and company/client SOPs and guidelines . Maintain document version control and ensure timely completion of assigned deliverables. Participate in authoring/review meetings and cross-functional project meetings. Assist Senior Medical Writers with document planning, tracking, and project coordination. Maintain awareness of current medical writing practices, regulatory requirements, and industry standards. Support process improvement and development/update of templates, style guides, and work instructions. Required Qualifications Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related field . 1–3 years of experience in medical writing, clinical research, pharmaceutical/biotechnology, CRO, or a related environment. Strong scientific and medical writing skills. Basic understanding of: Clinical trials and drug development ICH-GCP FDA regulatory requirements Clinical research terminology Clinical trial documentation Experience with scientific literature searches and referencing. Excellent written and verbal communication skills. Strong attention to detail and ability to identify inconsistencies or errors. Ability to understand and summarize complex scientific information. Proficiency with Microsoft Word, Excel, and PowerPoint . Ability to manage multiple assignments and meet deadlines. Ability to work effectively in a cross-functional, matrix environment . Preferred Qualifications Master's degree, PharmD, PhD, or other advanced degree in a relevant scientific/healthcare discipline. Previous experience with CSRs, protocols, IBs, narratives, or regulatory documents . Experience working in a CRO, pharmaceutical, or biotechnology company . Familiarity with electronic document management systems and collaborative platforms such as SharePoint. Experience with Veeva Vault or similar clinical/regulatory document systems. Knowledge of CTD/eCTD structure and regulatory submissions. Experience in one or more therapeutic areas such as oncology, immunology, CNS, cardiovascular, rare disease, or infectious disease. #J-18808-Ljbffr

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