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    Medical Writer: Pharmaceutical

    Criterion Edge
    2+ years
    $75 to $90 per hour
    Remote, USA
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Pharmaceutical Medical Writer (1099 Contractor)

    Location: Remote
    Employment Type: Part-Time/Full-Time (1099 Contractor)
    Compensation: $75-$95/hour

    Company Overview:

    Criterion Edge is a leading provider of high-quality writing services in the pharmaceutical and biotechnology sectors. We specialize in delivering customer-focused regulatory and scientific writing solutions for our clients. As a member of our best-in-class writing team, you will contribute to advancing the field through the production of clear, accurate, and high-quality documents.

    Position Overview:

    We are seeking an experienced Pharmaceutical Medical Writer to join our dynamic writing team. This remote position offers the flexibility of part-time or full-time work and provides the opportunity to collaborate with talented professionals across a variety of projects for top-tier pharmaceutical and biotech clients. This position is ideal for a mid-level writer with a strong background in clinical and regulatory writing, who is looking to grow within a fast-paced, client-focused environment.

    Key Responsibilities:

    • Develop High-Quality Content: Produce accurate and scientifically sound regulatory and scientific reports, including clinical protocols, clinical study reports (CSRs), investigator's brochures, and briefing books, ensuring all documents adhere to project specifications, timelines, and budgets.
    • Client & Team Interaction: Work closely with clients, project managers, and other medical writers to ensure scientific accuracy, clarity, and quality of deliverables. Lead client and internal meetings as required.
    • Data Interpretation: Analyze and interpret complex clinical and non-clinical datasets to inform document content and ensure regulatory compliance.
    • Mentorship & Editing: Edit content produced by others, providing guidance and mentorship to junior writers to enhance clarity, accuracy, and quality.
    • Project Management: Collaborate with the Criterion Edge Project Manager to organize your workload, provide time estimates, and submit weekly progress updates. Identify project risks and propose solutions.
    • Quality Control: Perform and coordinate quality control (QC) checks, ensuring documents meet the highest standards for accuracy and compliance.
    • Communication & Collaboration: Maintain strong communication with clients and team members to meet project goals and deadlines. Provide constructive feedback to junior team members and clients when appropriate.

    Qualifications & Skills:

    • Experience: 4+ years of experience in the pharmaceutical industry, with at least 3 years in clinical and regulatory writing.
    • Education: A BSc in a life sciences or related discipline is required.
    • Regulatory Expertise: Experience in writing and editing clinical and nonclinical regulatory documents such as clinical protocols, CSRs, investigator's brochures, and briefing books.
    • Technical Skills: Advanced proficiency in Microsoft Office (Word, Excel), Adobe Acrobat, and collaborative document-sharing platforms (e.g., SharePoint). Ability to learn and adapt to various IT systems.
    • Communication: High level of English fluency (native-level preferred) with excellent oral, written, and technical communication skills.
    • Attention to Detail: Exceptional attention to detail and accuracy in writing, editing, and data verification.
    • Independent Work Ethic: Ability to work independently, manage multiple projects, and meet deadlines with minimal supervision.
    • Team Collaboration: Strong team player with the ability to collaborate effectively and contribute to the success of the team.

    Benefits:

    • Flexible Schedule: Remote work with flexible hours.
    • Competitive Compensation: $75-$95/hour based on experience.
    • Contractor Status: This is a 1099 contractor position with the possibility of both part-time or full-time work.

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