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    Senior / Medical Writer

    Hoya Surgical Optics
    5-8 years
    Not Disclosed
    Irvine
    10 July 23, 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, 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

    About the Job: Medical Writer at HOYA Surgical Optics (HSO)

    About HOYA Surgical Optics (HSO)

    HOYA Surgical Optics (HSO) is a global leader in Preloaded Intraocular Lens (IOL) technology, providing innovative solutions that help ophthalmic surgeons restore sight and improve the vision and quality of life for millions of cataract patients. Our commitment to excellence drives us to exceed expectations and deliver superior surgical outcomes and practice results through a continuously improving quality management system.

    At HSO, our people are the cornerstone of our success. We strive to create a supportive work environment and foster an inclusive culture grounded in our core values: Excellence, Passion, Innovation, Collaboration, and Accountability.

    HSO's Way of Working

    • Accountability: We take responsibility for our own capabilities and development.
    • Results-Oriented: We focus on delivering results without excuses.
    • Collaboration: We are mindful of the impact our work has on others and strive to support them effectively.

    Who We’re Looking For

    We seek individuals who:

    • Impact-Focused: Look beyond themselves and consider the broader impact of their work.
    • Considerate: Understand the needs, challenges, and objectives of everyone they interact with.
    • Supportive: Provide positive reinforcement to help others succeed.

    About the Role

    Location: California, Irvine (Remote working options available) Reports to: VP, Global Medical Affairs Function: Global Medical Affairs Key Collaborations: Clinical Affairs, R&D, Marketing

    Role Overview

    The Medical Writer will manage, author, and review budget-assigned clinically relevant documents, including clinical study reports, protocols, manuscripts for peer-reviewed scientific articles, brochures, and product manuals. These materials will cover clinical trials, procedures, medical devices, medical research/breakthroughs, clinical data, and medical education.

    Duties and Responsibilities

    • Develop clinically relevant documents for regulatory purposes and publications.
    • Interpret data and apply regulatory, compliance, and scientific knowledge to document preparation.
    • Manage medical writing projects supporting clinical development, trials, and filings.
    • Write and edit high-quality manuscripts, abstracts, white papers, brochures, regulatory documents, and product manuals.
    • Conduct literature reviews on cataracts, cataract surgical procedures, intraocular lenses, and related devices.
    • Collaborate with the Communications Team to create content calendars and timelines.
    • Conduct interviews with subject matter experts and IOL thought leaders.
    • Collaborate with internal R&D and Clinical Affairs teams to verify data.
    • Systematically review reports and cross-check information.
    • Perform quality control checks on submissions.
    • Ensure documents adhere to writing guidelines and are properly stored and organized.

    Requirements

    Experience:

    • Minimum of 8 years of medical writing experience.
    • 3-5 years in clinical, regulatory scientific positions in industry or academia.
    • Experience in cataract surgery devices, intraocular lenses, and Ophthalmology preferred.
    • Experience writing clinical study reports and manuscripts for peer-reviewed publications.

    Skills/Accreditations:

    • Advanced medical and scientific writing skills.
    • Ability to critically and systematically assess information.
    • Ability to translate complex clinical and technical information into simple oral and written forms.
    • Understanding of clinical data analysis and study design concepts.
    • Experience with medical device regulations and cross-functional collaboration.

    Academic Qualifications:

    • Higher scientific education in Medicine or related sciences (preferably Masters / OD/ PhD/ MD level).
    • Background in Ophthalmology preferred.

    Travel Requirements:

    • Up to 10%.

    By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. Only shortlisted applicants will be notified. Thank you for your understanding.

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