Medical Writer

Location: San Jose
Posted on: June 23, 2025

Job Description:

Job Description: We are looking for an experienced Medical Writer to support our clinical research programs across various therapeutic areas. As part of a KlinEra, this role plays a key part in producing high-quality scientific and regulatory documents that support drug development and approval processes. Ideal candidates will have strong writing and editing skills, a solid understanding of clinical trial documentation, and the ability to interpret complex scientific data clearly and accurately. Qualifications: Bachelor's degree in life science/related field, advanced degree preferred Minimum of 5 years in clinical research industry Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes. Proven ability to author manuscripts, abstracts, and presentations for scientific journals and conferences Ability to translate complex data into clear, accurate content for various audiences Deep understanding of clinical research, study design, statistics, and data interpretation Familiarity with regulatory and reimbursement landscapes (FDA submissions, CERs, HEOR) Ability to critically evaluate scientific literature Responsibilities: Write and submit peer-reviewed publications, abstracts, and white papers. Collaborate with and support key opinion leaders, including attending meetings to assist with presentations. Produce scientific content such as clinical summaries, op-eds, and white papers. Partner with clinical operations to develop study protocols and ensure data aligns with scientific goals. Align publication and podium plans with clinical trial timelines and escalate issues when needed. Ensure scientific rigor in preclinical and clinical research projects. Project manage preclinical research and related communications. Write and manage medical content for FDA submissions and Clinical Evaluation Reports (CERs). Conduct comprehensive literature reviews for regulatory documentation.Attend team events and industry meetings. Work with marketing to translate data into clear, compliant, and compelling messages. Support medical communications review of promotional materials and competitor analysis. Develop study-related documents such as informed consent forms (ICFs) and study manuals Assist with the collection and submission of regulatory documents Ensure timely resolution of data queries and documentation discrepancies Review and report on safety data and ensure proper documentation and follow-up Conduct study close-out visits and ensure study documentation is complete Ensure proper archiving of essential study documents Maintain regular communication with investigators, study coordinators, and sponsors Provide status updates and contribute to project team discussions Skills: Strong writing and editing skills, especially for scientific and clinical content Excellent verbal and written communication Strong attention to detail High level of independence and proactivity Comfortable with in-person travel for conferences and KOL support What We Offer: Competitive salary Opportunity to work on cutting-edge projects and make a significant impact Supportive and dynamic work environment Professional development and growth opportunities Additional Information: Founded in 2005, KlinEra is a global leader in providing innovative and customized clinical trial services designed to accelerate the delivery of novel therapeutic treatments. With a presence on every major continent and headquarters in Silicon Valley, KlinEra is committed to conducting ethical and efficient clinical trials, enabling faster patient access to groundbreaking therapies. With over 20 years of experience, KlinEra excels in various therapeutic areas, including gastroenterology, oncology, and neurology. Our deep understanding of these fields ensures compliance and supports the successful delivery of clinical trials. In addition to our core business functions, KlinEra is dedicated to giving back to the community through initiatives like KlinEducate, which educates the younger generation about the clinical research industry, and by providing affordable medical care to over 1,200 patients monthly in India. If you can resonate with what KlinEra provides as a company, please join our pipeline.

Keywords: , San Bruno , Medical Writer, Science, Research & Development , San Jose, California