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    Senior Medical Writer / Senior Project Manager, Clinical Evaluation

    Abbott
    2+ years
    $83,600.00 – $167,200.00
    Santa Clara
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: RN/PharmD/PhD/MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Here’s a summary of the Senior Medical Writer/Project Manager position at Abbott:

    Organization:

    Abbott

    Position Overview

    Abbott is seeking a Senior Medical Writer/Project Manager for their Vascular Clinical Evaluation Products team. The role involves supporting regulatory affairs submissions, including CE marking for new devices and maintaining CE marks for existing products, according to the European Commission Guidelines. The Medical Writer/Project Manager will guide the development of clinical evaluation reports (CERs) and other related documents, ensuring compliance with relevant regulations.

    Key Responsibilities

    • Clinical Evaluation Documentation: Create and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs), and related documentation for regulatory submissions.
    • Clinical Evidence Review: Evaluate and summarize clinical evidence, including clinical investigations, literature, post-market surveillance, and risk evaluations.
    • Cross-functional Communication: Collaborate with teams such as Regulatory Affairs, R&D, Clinical R&D, Quality Engineering, and more to obtain relevant data and documents.
    • Regulatory Submissions: Lead and support the development of regulatory responses for Notified Body questions and review submission materials.
    • Project Management: Manage timelines, risks, and deliverables using project management tools, ensuring alignment with cross-functional teams.
    • Strategic Guidance: Provide guidance on regulatory requirements and clinical evaluation to product development teams.
    • Audit Support: Participate in audits and address audit findings, ensuring compliance with regulatory standards.

    Required Qualifications

    • Education: Bachelor’s Degree in Science, Medical Technology, or a relevant technical discipline, or equivalent experience.
    • Experience: Minimum 3 years in a related area (e.g., R&D, Technical Product Development, or Quality in healthcare industries).
    • Skills: Experience writing technical documentation, managing projects, analyzing clinical data, and using project management tools.
    • Communication: Strong verbal and written communication skills with the ability to manage multiple projects simultaneously and meet deadlines.

    Preferred Qualifications

    • Advanced Education: Master’s degree, RN, PharmD, PhD, or MD.
    • Regulatory Experience: Experience writing CERs in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions.
    • Regulatory Knowledge: Familiarity with medical device regulations, including ISO 14971, ISO 14155, ISO 13485, and related clinical and quality standards.
    • Certifications: Certifications such as RAC and PMP are a plus.
    • Cardiovascular Device Experience: Experience with cardiovascular medical devices is highly preferred.

    Salary Range

    • Base Pay: $83,600.00 – $167,200.00 annually (may vary depending on location).

    Benefits

    • Health Investment Plan (HIP) PPO: Free medical coverage for employees who complete a wellness assessment.
    • Retirement Savings Plan: High employer contribution.
    • Tuition Reimbursement and Education Benefits: Including Freedom 2 Save student debt program and FreeU education benefit.
    • Other Benefits: Abbott offers a comprehensive health and wellness benefits package to help employees and their families live full lives.

    Company Overview

    Abbott is a global healthcare leader known for its innovations in diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 employees serving people in more than 160 countries, Abbott is recognized for its commitment to employee development, diversity, and workplace excellence.

    Abbott offers a dynamic work environment with opportunities to contribute to cutting-edge medical technologies and help improve lives worldwide.

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