Medical Writer II

Icon Gaithersburg , MD 20877

Posted 2 months ago

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Write, review, manage, and QC documents for clients including synopses, protocols, clinical study reports, protocol and clinical study report amendments, narratives, investigator brochures, and other regulatory documents as required, to meet scientific and regulatory standards as applicable.

Review for quality as well as interpret, analyze, summarize, and present data for clinical studies from sources such as tables, listings, and figures into clinical study reports and other study summaries as required.

Liaise with other functional groups ( scientific, project management, and publishing staff) to insure timely delivery and quality of writing deliverables.

A minimum of 2 years of relevant experience in clinical pharmacology, early clinical drug development (phase 1-2a), clinical research, regulatory science and preparing applicable clinical research documentation, with a substantial amount of that experience being in healthy volunteer (clinical pharmacology) studies such as: First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetic (PK), Pharmacokinetic-pharmacodynamics (PK-PD), Bioavailability/Bioequivalence (BA/BE), biosimilar, Food Effect (FE), Drug-Drug Interaction (DDI), Thorough QT (TQT), renal impairment and hepatic impairment, as well as proof-of-concept (POC) and early patient studies.

Most of this experience should be in small molecules, with additional experience in biologics/vaccines/devises a plus. Prefer this experience in a CRO environment and/or Pharmaceutical Company knowledge of clinical trial and drug development processes.

Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat.

Bachelor's degree or local equivalent, preferably in a biomedical sciences, plus additional medical and/or relevant scientific education or experience. Advanced degree (Master's, PhD, MD, or local equivalent) a strong plus.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.



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Medical Writer II

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