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Global drug and device development services

Technical Medical Writer 2 - Biomarker Services

Technical WritingConfirmed live in the last 24 hours
Full-timeFarmingdale, NY, USA

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific, clinical, or regulatory field is required; an advanced degree such as an MSc, PhD, PharmD, or MD is preferred.
  • A minimum of 3 years of relevant medical or scientific writing experience within the pharmaceutical, biotechnology, contract research organization, clinical research, or clinical laboratory industry is required.
  • Excellent scientific writing, editing, and proofreading skills, strong knowledge of scientific and medical terminology, and the ability to communicate complex information clearly and concisely.
  • Strong analytical and critical-thinking skills, including the ability to review, interpret, and summarize clinical, scientific, and laboratory data and identify key findings, trends, and inconsistencies.
  • Familiarity with clinical research processes, applicable regulatory requirements, industry guidelines, and scientific documentation standards.
  • Strong attention to detail and a demonstrated commitment to scientific and data accuracy.
  • Ability to work independently while collaborating effectively with scientific, laboratory, clinical, regulatory, quality, and project teams.
  • Ability to manage multiple projects and priorities within a deadline-driven environment.
  • Strong interpersonal and communication skills, including the ability to interact effectively with internal stakeholders and clients.
  • Proficiency with Microsoft Office applications, particularly Word, and familiarity with PDF editing, document publishing, and electronic document management systems.

Responsibilities

  • Prepare, write, edit, and review clinical and scientific documents, including end-of-study reports, laboratory sample testing plans, standard operating procedures, protocols, and other supporting documents.
  • Review, interpret, and summarize clinical and laboratory testing data accurately and concisely within required reports, formats, and templates.
  • Ensure document accuracy, completeness, consistency, and alignment with study requirements, internal standard operating procedures, and applicable regulatory requirements.
  • Collaborate with clinical testing laboratories, scientific subject matter experts, Data Management, Regulatory Affairs, Medical Affairs, Project Management, and Quality Assurance to obtain and clarify information required for document development.
  • Participate in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, data, and deliverables, and provide scientific and editorial input on document content and presentation.
  • Conduct and coordinate quality-control reviews to ensure scientific accuracy, data integrity, formatting consistency, and overall document quality.
  • Manage assigned writing activities and priorities to meet project timelines and deliverables.
  • Provide guidance and support to junior medical writers, as appropriate.
  • Maintain awareness of relevant scientific developments, clinical research practices, regulatory requirements, and industry guidelines.

Desired Qualifications

  • Experience with clinical laboratory testing, biomarker data, or laboratory-generated reports is preferred.
  • Candidates with an advanced scientific degree and substantial relevant scientific writing experience may be considered where their experience demonstrates equivalent scientific, analytical, and writing capabilities relevant to the position.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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