Medical Writer II

Icon Gaithersburg , MD 20877

Posted 1 week ago

ICON is currently hiring a Medical Writer II to be based remotely anywhere in the United States. The ideal candidate will have 2-5 years' experience in either Early Phase Medical Writing or Medical Writing for a CRO/Pharma Company. However, more senior candidates should still apply.

Position Summary:

To review and interpret clinical data; to independently write, edit, review, QC and compile complex documents; to manage medical writing tasks; to ensure the accuracy and quality of applicable written deliverables and their compliance with ethical, legal, regulatory, and client standards.

Job Functions/Responsibilities:

  • 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 (eg scientific, project management, and publishing staff) to ensure timely delivery and quality of writing deliverables

  • Independently interact with clients to obtain necessary and relevant information, and deal with queries through effective decision making.

  • Write regulatory submissions and/or relevant sections as required.

  • Insure proper version control of all applicable documents.

  • Participate in and/or lead processes improvement initiatives such as establishing and improving document standards, process mapping and documentation, SOP authoring, review, and revision, or other procedures.

  • Participate and assist management in improving efficiencies of MW processes with respect to quality, cost, and time

  • Define, collect, track, and report on metrics

  • Assist in growing and managing the CRD/MW resources including relevant literature, example documents, style guides, and templates

  • Develop and present training on areas of expertise as related to CRD/MW processes and deliverables as well as client and industry standards (ie, Lunch and Learn presentations)

  • Resolve issues and escalate problems as necessary

  • To undertake other reasonably related duties as may be assigned from time to time.

  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients, and Performance.

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Travel (approximately <5%) domestic="" and/or="">

Knowledge, Skills, and Abilities:

  • 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-pharmacodynamic (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/devices a plus.

  • Prefer this experience in a CRO environment and/or Pharmaceutical Company

  • Ability to work efficiently without supervision.

  • Knowledge of clinical trial and drug development processes.

  • Knowledge of scientific and regulatory requirements as they apply to clinical pharmacology studies, specific protocols, and clinical study reports.

  • Excellent written and verbal communication skills, data-interpretation skills, strong interpersonal skills, ability to plan and organize.

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

  • Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating.

Education Requirements:

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

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Medical Writer II