Job Description
Apex Health Systems is a pioneering force in the biotechnology sector, dedicated to revolutionizing patient outcomes through innovative research and data-driven solutions. We are seeking a highly skilled and detail-oriented Senior Medical Writer & Clinical Data Specialist to join our elite communications team in San Francisco.
In this pivotal role, you will bridge the gap between complex clinical data and actionable medical insights. You will be responsible for authoring high-impact scientific manuscripts, ensuring regulatory compliance, and managing critical clinical datasets that drive our product development pipelines.
Join a culture that values precision, integrity, and collaboration. If you are passionate about storytelling through data and want to make a tangible difference in global healthcare, apply today.
Responsibilities
- Author and edit high-quality clinical study reports, protocols, and regulatory submissions (e.g., IND, NDA) ensuring adherence to FDA and EMA guidelines.
- Analyze complex datasets using SQL and statistical software to extract key insights for manuscripts and presentations.
- Collaborate cross-functionally with clinical operations, regulatory affairs, and medical affairs teams to define project scopes and deliverables.
- Mentor junior writers and data analysts, providing technical guidance on writing standards and data integrity protocols.
- Ensure all medical content is accurate, clear, and accessible to both scientific and non-scientific audiences.
- Conduct thorough literature reviews and maintain up-to-date knowledge of therapeutic areas and regulatory trends.
- Manage project timelines and deliverables using agile project management methodologies.
Qualifications
- Master’s or PhD degree in Medicine, Life Sciences, Pharmacy, or a related field.
- Minimum of 5 years of experience in medical writing, clinical research, or medical communications within the pharmaceutical or biotech industry.
- Strong proficiency in SQL, R, or Python for data manipulation and analysis.
- Extensive knowledge of ICH-GCP guidelines, FDA 21 CFR Part 11, and EMA regulations.
- Exceptional command of the English language with a demonstrated portfolio of published scientific papers or regulatory submissions.
- Experience with content management systems (CMS) and version control software (e.g., SharePoint, Git).
- Strong attention to detail and ability to work under tight deadlines in a fast-paced environment.