Senior Medical Writer

Job not on LinkedIn

🔥 13 hours ago

🌵 Arizona, Connecticut, +10 more states – Remote

🌵 Arizona – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote ⛷️ Utah – Remote ⚔️ Virginia – Remote

💵 $84.4k - $120.5k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 0%

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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Perceptive Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Perceptive Inc. is a leading provider of scientific and data-driven solutions for the bio-pharmaceutical industry, focusing on oncology, central nervous system (CNS) therapeutic areas, and musculoskeletal imaging. With expertise in drug discovery, preclinical and early clinical imaging, and radiochemistry, Perceptive offers services that identify promising candidate compounds and mitigate risks through premier imaging services. It also provides comprehensive eClinical solutions, including Randomization and Trial Supply Management (RTSM), aimed at optimizing clinical trial processes. Trusted for its high-quality data, Perceptive serves as a partner in advancing clinical trials and bringing essential treatments to patients faster, backed by over 50 years of experience and a team of dedicated experts. Perceptive's global presence ensures seamless delivery of Discovery, eClinical, and Imaging services to support worldwide clinical trials.

📋 Description

• Create, research, edit and coordinate production of clinical documents related to independent review • Prepare clinical documents for submission to regulatory authorities • Prepare clinical documents not intended for regulatory submission • Revise drafts based on review comments from team members • Follow SOPs, templates, guidelines, regulations, client instructions and applicable processes • Perform literature searches and reviews for background information and training • Draft or ghost-write clinical documents for more experienced medical writers • Support team members to ensure documentation is accurate and meets stakeholder needs • Participate in process improvement and training initiatives, including development of SOPs, central content, guidelines and workflow procedures • Participate in marketing initiatives such as white papers, abstracts, posters and manuscripts • Serve as primary client contact for medical writing projects • Negotiate deliverable timelines and resolve project-related issues • Represent medical writing on assigned project teams and facilitate authoring team meetings • Coordinate and conduct interdepartmental reviews of draft and final documents • Evaluate task progress, identify issues, facilitate resolutions and advance documents to approval • Distribute final documents to project teams and clients on agreed timelines • Identify project challenges and raise them with stakeholders, suggesting resolution options • Attend project team meetings and maintain project documentation • Provide project management of contractual and financial aspects when required • Implement stakeholder engagement and communications plans • Manage problems, issues, resolutions, corrective actions and lessons learned • Collect and use stakeholder feedback to measure relationship-management effectiveness • Develop and enhance customer and stakeholder relationships • Develop, maintain, control and distribute documents using systematic quality methods • Prepare documents for publishing readiness and ensure consistency and integrity • Ensure documentation adheres to FDA, EMA and other applicable regulatory guidelines and SOPs • Perform medical editing reviews of draft and final documents, including copyediting and content review • Control updates and distribution of quality standards • Carry out other reasonable duties as requested

🎯 Requirements

• Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience • Fluent English, written and verbal • Non-English language, written and verbal, desirable • Solid professional experience in the same or very similar role • Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications • Experience working in and knowledge of the life sciences sector • Solid knowledge of industry guidelines and regulations, including ICH-GCP • Experience of regulated environments • Understanding of Agile methodologies • Experience using tools to communicate progress to stakeholders • Proven ability to use Microsoft Office products, including Word, Excel and PowerPoint • Demonstrable ability to apply critical thinking to problems and tasks • Ability to consistently produce documents of high quality • Ability to manage multiple and varied tasks and prioritize workload with attention to detail • Ability to work methodically in a fast-paced, time-sensitive environment • Ability to identify and implement process improvements • Ability to negotiate on behalf of medical writing to align resources, timelines and expectations • Up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements affecting technology within the life sciences domain • Ability to work under own initiative • Experience using data analysis tools such as Tableau or Power BI desirable

🏖️ Benefits

• Medical, Dental and Vision benefits for you and your family • Flexible Spending Accounts (FSA) • Health Savings Accounts (HSAs) • Paid time off policy including holidays and sick time • Internal growth and development programs & trainings • 401(k) program • Life & accident insurance • Disability insurance