{"id":6173,"date":"2026-05-19T13:45:58","date_gmt":"2026-05-19T13:45:58","guid":{"rendered":"https:\/\/jobs.eightelevengroup.com\/jobs\/job\/a1wcv000000awnxeam-lead-medical-writer-dublin-ohio\/"},"modified":"2026-05-19T17:09:13","modified_gmt":"2026-05-19T17:09:13","slug":"a1wcv000000awnxeam-lead-medical-writer-dublin-ohio","status":"publish","type":"job_listing","link":"https:\/\/jobs.eightelevengroup.com\/jobs\/job\/a1wcv000000awnxeam-lead-medical-writer-dublin-ohio\/","title":{"rendered":"Lead Medical Writer"},"content":{"rendered":"<h4 id=\"myCustomID\"><strong><a href=\"https:\/\/jobs.eightelevengroup.com\/apply-now\/?job_title=Lead Medical Writer&#038;job_id=a1Wcv000000aWNxEAM\">Apply Now<\/a><\/strong><\/h4>\n<p><strong><a href=\"https:\/\/jobs.eightelevengroup.com\"><< Return to Search Results<\/a><\/strong><\/p>\n<p>Lead Medical Writer<\/p>\n<p> Remote (must be based in EST)<\/p>\n<p> Compensation: $80\u2013$90 per hour<\/p>\n<p> Contract Length: 2 month Contract to Hire (40 hours\/week)<\/p>\n<p> Start Date: 7\/1\/26<\/p>\n<h3><\/h3>\n<h3>ABOUT THE ROLE<\/h3>\n<p>Our client is a global healthcare services and products company providing pharmaceuticals, medical products, and supply chain solutions to hospitals, pharmacies, and healthcare providers. The organization plays a critical role in helping healthcare systems improve efficiency, reduce costs, and enhance patient care through integrated distribution and data-driven solutions. As a Lead Medical Writer on a 2-month remote contract, you will autonomously author and review a range of clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and responses to health authority queries. You will contribute scientifically and strategically to submission teams, plan data analyses, review statistical analysis plans, and collaborate with cross-functional stakeholders such as Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs. This role requires advanced medical writing skills, deep knowledge of regulatory requirements, the ability to mentor junior writers, and strong interpersonal and presentation abilities. Candidates must be available to work in the Eastern Standard Time zone.<\/p>\n<h3><\/h3>\n<h3>WHAT YOU&#8217;LL DO<\/h3>\n<ul>\n<li>Autonomously write and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and other regulatory submissions such as responses to health authority questions, briefing books, 120-day safety updates, pediatric investigational plans, and investigator brochures<\/li>\n<li>Contribute scientifically and strategically to submission teams at the project and\/or study team level, providing input on pooling strategy, content expertise, and guidance on regulatory requirements<\/li>\n<li>Plan and review data analyses and presentations for CSRs; review statistical analysis plans and related documents<\/li>\n<li>Collaborate effectively with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs<\/li>\n<li>Work with in-house Documentation Specialists to produce high-quality final documents and ensure timely delivery<\/li>\n<li>Mentor and develop junior medical writers, providing guidance and support as needed<\/li>\n<li>Demonstrate advanced medical writing skills and maintain up-to-date knowledge of regulatory document requirements and guidelines<\/li>\n<li>Work independently and as part of a team, managing multiple priorities and meeting challenging deadlines<\/li>\n<li>Exhibit excellent interpersonal and presentation skills in all interactions<\/li>\n<li>Maintain advanced proficiency in English for all written and verbal communications<\/li>\n<\/ul>\n<h3>WHAT YOU BRING<\/h3>\n<ul>\n<li>Advanced degree in life sciences (PhD, PharmD, MD, or MS preferred)<\/li>\n<li>5+ years of regulatory\/medical writing experience in the pharmaceutical industry across several therapeutic areas<\/li>\n<li>Proven ability to autonomously write and review clinical regulatory documents (e.g., CTD Module II summaries, CSRs, Clinical Overviews, Investigator brochures, and other regulatory submissions)<\/li>\n<li>Strong knowledge of regulatory document requirements and guidelines<\/li>\n<li>Experience contributing scientifically and strategically to submission teams<\/li>\n<li>Ability to plan data analyses and review statistical analysis plans for CSRs<\/li>\n<li>Excellent collaboration skills with cross-functional stakeholders<\/li>\n<li>Well-developed medical writing skills with attention to quality and deadlines<\/li>\n<li>Ability to mentor and develop junior medical writers<\/li>\n<li>Ability to work independently and as part of a team<\/li>\n<li>Strong interpersonal and presentation skills<\/li>\n<li>Advanced level of English proficiency<\/li>\n<li>Ability to work under pressure and meet challenging deadlines<\/li>\n<li>Remote work capability with availability in Eastern Standard Time (EST)<\/li>\n<\/ul>\n<p>Lead Medical Writer Dublin, Ohio<\/p>\n<p>For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it\u2019s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company\u2019s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That\u2019s the Medasource promise.<\/p>\n<p><i>Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.<\/i><\/p>\n<p dir=\"auto\" align=\"left\"><span style=\"text-decoration: underline;\"><strong>Benefits &#038; Perks:<\/strong><\/span><\/p>\n<p dir=\"auto\" align=\"left\"><em><strong>Medasource<\/strong> offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee\u2019s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.<\/em><\/p>\n<p dir=\"auto\" align=\"left\"><span style=\"text-decoration: underline;\"><strong>Pay Disclaimer:<\/strong><\/span><\/p>\n<p dir=\"auto\" align=\"left\"><em>The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.<\/em><\/p>\n<p class=\"custom-white\">a1Wcv000000aWNxEAM<\/p>\n<h4 id=\"otherId\"><strong><a href=\"https:\/\/jobs.eightelevengroup.com\/apply-now\/?job_title=Lead Medical Writer&#038;job_id=a1Wcv000000aWNxEAM\">Apply Now<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":220,"template":"","meta":{"inline_featured_image":false,"_promoted":"","_job_location":"Dublin, Ohio","_application":"applications@staffingfuture.com","_company_name":"Medasource","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-types":[7],"class_list":{"0":"post-6173","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"has-post-thumbnail","5":"hentry","7":"job-type-contract-to-hire"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Lead Medical Writer, Dublin Ohio<\/title>\n<meta name=\"description\" content=\"Lead Medical Writer, Dublin Ohio\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jobs.eightelevengroup.com\/jobs\/job\/a1wcv000000awnxeam-lead-medical-writer-dublin-ohio\/\" \/>\n<meta property=\"og:locale\" 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