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Medical Writer II – Publications
Location
Arizona + 3 moreAll locations: Arizona | Maine | Ohio | Rhode Island
Posted
69 days ago
Salary
$70.1K - $145K / year
Seniority
Senior
Job Description
Medical Writer II – Publications
Syneos Health
• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. • Coordinates quality and editorial reviews. • Ensures source documentation is managed appropriately. • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. • Provides feedback to further define statistical output required and document needs. • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. • Mentors and leads less experienced medical writers on complex projects, as necessary. • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
Job Requirements
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
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Clinical Documentation Specialist
UTMB Health - University of Texas Medical BranchUTMB Health, also known as The University of Texas Medical Branch, is an award-winning healthcare system based in Galveston, Texas. A nationally recognized teac
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Johnson & JohnsonJohnson & Johnson is an award-winning, family-owned-and-operated company that has been providing health and wellness products for more than 120 years. Employing
Title: Manager, Medical Writer - Scientific Communications Location: Horsham, Pennsylvania, United States of America Hybrid Work time type: Full time job requisition id: R-073625 Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Medical Affairs Group Job SubFunction: Medical Writing Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America Job Description: Johnson & Johnson US Medical Affairs is recruiting for a Manager Medical Writer located in our Horsham, Pennsylvania. This is a hybrid role that will require 3 days in the Horsham office. We are looking for a Manager Medical Writer to join the Scientific Communications team, supporting our Immunology therapeutic area. The writer will support publications (e.g., manuscripts, abstracts, posters, presentations, and slide decks) as assigned, to develop peer-reviewed publications and congress submissions communicating data from our company-sponsored clinical and observational studies in addition to real-world evidence analyses. Key Responsibilities: - Collaborate with Johnson & Johnson US and global stakeholders, authors, and steering committee members throughout the publication development process. 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Lead mock-up development of data displays (e.g., tables and figures). - Identify and resolve, with the help of other functional areas, clinical and statistical issues in the interpretation of clinical data. - Conduct detailed literature reviews for topics of interest related to project documents using various repositories. - Demonstrate mastery of relevant publication guidance, including but not limited to International Committee of Medical Journal Editors (ICJME), Good Publication Practices (GPP), CONSORT Guidelines, American Medical Association (AMA) Manual of Style, and other guidelines pertaining to study protocols and clinical study reports. - May perform other duties as assigned. 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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. 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