Position Overview: We are seeking a highly qualified and experienced Senior Medical Writer to join our team. The ideal candidate will have over 10 years of experience in medical writing, with a proven track record of producing high-quality, scientifically accurate, and regulatory-compliant documents. This role offers the opportunity to work on a variety of projects, collaborate with cross-functional teams, and contribute to the success of our clients and products. Key Responsibilities: Lead the development of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submission documents. Ensure all documents are scientifically accurate, clear, and adhere to regulatory guidelines and company standards. Collaborate with cross-functional teams, including clinical research, regulatory affairs, biostatistics, and project management, to gather and interpret complex scientific data. Provide strategic input and expertise on clinical development plans, regulatory strategies, and publication plans. Mentor and guide junior medical writers, providing training and feedback to foster professional growth and development. Stay current with industry trends, regulatory requirements, and best practices in medical writing. Qualifications: A minimum of 8-10 years of experience in medical writing within the pharmaceutical, biotechnology, or medical communications industries. Extensive knowledge of clinical development and regulatory processes. Exceptional writing, editing, and communication skills, with a keen attention to detail. Strong organizational skills and the ability to manage multiple projects and deadlines simultaneously. Proficiency in Microsoft Office Suite and familiarity with document management systems. Ability to work independently and as part of a collaborative team. #J-18808-Ljbffr Nexus Contingent Workforce
Description Location: UCHealth UCHlth Poudre Valley Hospital, US:CO:Fort Collins Department: PVH Birthing Center FTE: PRN, 0.0, 0.00 hours... ...Requirements: High School diploma or GED or Military trained. State Surgical Assistant or Surgical Technologist registration. Basic...
...and solve problems they care about. We are currently looking for individuals to fill the following Summer Camp position at Camp La Jita . La Jita, meaning precious possession, was aptly chosen as the name for our resident camp on the beautiful Sabinal River near...
...certifications and various lead roles Malpractice liability insurance Summary: Presbyterian is seeking an experienced Pre Op... ...anesthesia after surgery. They monitor post-operation vital signs, assess levels of consciousness, and carefully observe patients for any...
...Job Description About the Role Wirecutter is seeking a home decor staff writer to join our discovery team, a group of writers... ...collaborating with a visuals or photo team on art and content packaging Demonstrate support and understanding of our value of journalistic...
...Responsibilities Join the WINNING TEAM at IGT Global! IGT seeks a Lottery Field Services Technician in the San Jose, Fremont, Hayward, CA. The Lottery Field Services Technician is responsible for servicing IGT equipment at retailer (customer) locations and will be...