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    Senior Medical Writer (Remote)

    Mms
    3-5 years
    Not Disclosed
    India
    10 Sept. 7, 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

    Medical Writer

    About MMS:

    MMS is a forward-thinking, data-driven CRO that excels in supporting the pharmaceutical, biotech, and medical device industries. Our expertise in handling complex trial data and regulatory submissions, combined with our technology-enabled services, makes MMS a trusted partner in drug development. With a global presence across four continents and a 97 percent customer satisfaction rating, MMS has been recognized as a top CRO by Global Health & Pharma’s international awards for the past three years. For more information, visit www.mmsholdings.com or follow us on LinkedIn.

    Responsibilities:

    • Evaluate, analyze, and interpret medical literature to select primary resource materials, ensuring study design, statistical significance, scientific rigor, and bias-free information.
    • Write and edit a variety of clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and journal publications.
    • Complete writing assignments on schedule and manage timelines and workflows effectively.
    • Provide exceptional internal and external customer service.
    • Demonstrate proficiency with various regulatory document styles and client templates/style guides.
    • Independently interact with clients to coordinate all project aspects and maintain effective communication.
    • Contribute to or manage the production of interpretive guides and take ownership of assignments, consulting with team members and departments as needed.
    • Mentor medical writers and other project team members involved in the writing process.

    Requirements:

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

    If you are an accomplished medical writer with a strong background in regulatory writing and team leadership, we encourage you to apply and contribute to our continued success at MMS.

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