Medical Writer – Contractor

Job not on LinkedIn

🔥 5 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🏥📝 Medical Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Sitero

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.

📋 Description

• Create documents for pre-marketing and post-marketing clinical trials, medical affairs, safety data, product development, license applications, and post-marketing maintenance • Analyze, review, and interpret non-clinical and clinical safety data and other relevant sources • Author and review aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports/ACO/DSURs, and other safety reports, for submission to health authorities • Author and review Risk Management Plans • Author and review clinical documents such as Clinical Study Reports and Protocols • Perform qualitative and quantitative signal assessment • Perform literature searches and present relevant articles for aggregate reports • Manage and reconcile relevant process trackers • Serve as a subject matter expert and train and mentor individuals • Generate Periodic Safety Line Listings from safety databases • Handle regulatory agency and Pharmacovigilance Risk Assessment Committee inquiries • Provide reliable support for high-priority ad-hoc activities • Ensure client deliverables comply with regulatory requirements and are sent within agreed timelines • Collaborate with Regulatory Affairs on reporting pharmacovigilance and drug safety information to regulatory agencies and prescriber communities • Train and mentor Pharmacovigilance associates

🎯 Requirements

• Minimum 2 years of experience in Medical Writing • Degree in Life Science/Pharma or Equivalent • Proficient computer knowledge and computer keyboarding skills • Proficient with Microsoft Office Suite (Outlook, Word, Excel) • Strong verbal, written and interpersonal communication skills • Strong organization and prioritization skills; able to multitask • Flexibility to adapt and meet fluctuating business priorities • Able to occasionally work extended and/or flexible schedule to meet client requirements • Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders • Excellent verbal, written and presentation skills • Innovative, collaborative, initiative-taker

🏖️ Benefits

• Hourly rate commensurate with Drug Safety medical writing experience level • Contract, as-needed agreement to be extended in the form of a Scope of Work consulting document