Advanced Clinical

  • Medical Writer

    Job Locations US-Nationwide
    Req No.
    2018-9724
    Category
    Biotech/R&D/Science
    Type
    Regular Full-Time
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

    ***This position can be remote based and worked from your home office*** 

     

    The Medical Writer is responsible for preparing clinical study documents, performing quality control functions for clinical study documents, and for performing project-related administrative tasks.  

    Responsibilities

    • Follow Standard Operating Procedures (SOPs)
    • Prepare methods and results sections of clinical study documents under the supervision of a writing director/manager including:regulatory documents, CSRs, protocols, ICs, clinical study reports, IND or NDA sections, etc.

    • Perform standard quality control (QC) functions in the clinical writing group (e.g., QC in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc.)
    • Assist with project-related administrative tasks (e.g., copying of data and insertion into tabbed binders, replacing old data with new data, etc.)

    Qualifications

    • Bachelor’s degree in the life sciences or a closely related field
    • Minimum of 2 years experience in clinical writing in the pharmaceutical industry to include regulatory documents, CSRs, protocols, ICs, clinical study reports, IND or NDA sections, etc.
    • Expert word processing skills in MS Word 2003, including proficiency with tables, graphs, and figures are required.
    • Proficient writing skills and must be conversant in regulatory guidelines relevant to clinical documents.
    • Knowledge of regulatory submission requirements and processes is preferred.
    • Fluency in English, excellent oral and written communication skills, attention to detail, project management skills, and organizational skills are required.
    • Must be able to work in a collaborative team environment.

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

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