Join to apply for the Medical Writer role at BioSpace 5 days ago Be among the first 25 applicants Join to apply for the Medical Writer role at BioSpace 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., CDSCO/ DCGI, FDA), 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 (DCGI 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 DCGI 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Marketing, Public Relations, and Writing/Editing Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Medical Writer jobs in San Jose, CA . Technical Writer - Medical device (Hybrid: Sunnyvale, California) W2 Only Newark, CA $77,000.00-$102,600.00 2 weeks ago Redwood City, CA $190,000.00-$235,000.00 1 week ago Technical Writer ( Must Have MadCap Flare, Medical Device, Product Labeling) Technical Writer (Medical Device Product Labeling, Project Coordination) San Francisco Bay Area $24.00-$27.00 8 hours ago Associate Director, Medical Writing (Regulatory) Redwood City, CA $144,800.00-$212,900.00 5 days ago Associate, Global Patient Safety Operations (TMF) Associate, Global Patient Safety Operations (TMF) Clinical Research Associate (Contract to Hire) Stanford, CA $81,130.00-$94,895.00 3 days ago (Paid Freelance) Human & Pet Study – Short Session Assistant Clinical Research Coordinator (Hybrid Opportunity) Social Science Research Professional 1 (Hybrid Opportunity) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr BioSpace
...CertiKs security-related services. Intersecting cybersecurity and blockchain, CertiKs security offerings include security consulting,... ...Responsibilities Work directly with the external blockchain developers to audit their code and secure their products including smart...
...the perfect time to join our clinical team! We are actively looking to hire talented Licensed Professional Clinical Counselors (LPCC) within our Frankfort, KY office, who are passionate about patient care and committed to clinical excellence....
...Bandman Interiors is a boutique full-service residential interior design firm located in North Beach. Although a small firm, we have a... ...of the office schedules/meetings, some remote work is allowed. A car is highly recommended! Benefits: Medical Stipend, Retirement...
...safety and innovation; they create and implement the most advanced training and technology the transportation industry has to offer. Driver: Job title in city, state proudly serving x school district(s); Any other unique selling points about the location Why join...
...Associate Director, Patient & Access Marketing Join to apply for the Associate Director, Patient & Access Marketing role at Domp... ...representatives (KAMs, FAMs, PAMs). The ideal candidate will have experience developing and executing patient focused marketing campaigns...