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    Senior Medical Writer (Remote)

    Mms
    3-5 years
    Not Disclosed
    Remote, USA
    10 Sept. 5, 2024
    Job Description
    Job Type: Full Time 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

    Position: Medical Writer

    Company: MMS Holdings

    Location: Remote

    About MMS Holdings:

    MMS Holdings is a leading, data-driven Contract Research Organization (CRO) specializing in supporting the pharmaceutical, biotech, and medical device industries. We offer a scientific approach to complex trial data and regulatory submission challenges. With a global presence spanning four continents and a 97% customer satisfaction rating, MMS Holdings is a recognized leader in the CRO sector, honored with awards from Global Health & Pharma for three consecutive years. For more information, visit www.mmsholdings.com or follow us on LinkedIn.

    Responsibilities:

    • Evaluate, analyze, and interpret medical literature to select appropriate resource materials for study design, statistical significance, scientific rigor, and absence of bias.
    • Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications for medical journals.
    • Complete writing assignments within set timelines and manage workflow efficiently.
    • Provide excellent internal and external customer service.
    • Demonstrate proficiency in various writing styles for regulatory documents and adherence to client templates and style guides.
    • Directly interact with clients to coordinate all project facets; exhibit strong communication skills.
    • Contribute to or manage the production of interpretive guides.
    • Take ownership of assignments, seeking information or guidance from project team members and other departments as needed.
    • Mentor medical writers and other team members involved in the writing process.

    Requirements:

    • At least 3 years of experience in the pharmaceutical industry.
    • 3-5 years of industry regulatory writing and clinical medical writing experience.
    • Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline preferred.
    • Substantial experience as a lead author of clinical study protocols.
    • Experience leading and managing teams while authoring regulatory documents under tight deadlines.
    • Experience with regulatory submissions (clinical study reports) to regulatory authorities is a plus.
    • Strong understanding of clinical data and federal regulations, Good Clinical Practices (GCP), and ICH guidelines.
    • Exceptional writing skills and ability to manage multiple tasks effectively.
    • Expertise in MS Word, Excel, PowerPoint, and other related word processing tools.
    • Experience as a project lead or in managing project teams.
    • Experience with orphan drug designations and PSP/PIPs is a plus, but not required.

    Apply Now:

    If you are a detail-oriented and experienced medical writer ready to contribute to impactful clinical development projects, we encourage you to apply. Join MMS Holdings and become part of a dedicated team committed to excellence in medical writing and regulatory submissions.

    Contact: Please reach out to us via our website for more information about the application process.

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