Cardinal Health · 3 days ago
Regulatory Technical Writer - Nationwide
Illinois, United States
Full-time
Remote
Mid Level
$94K/yr - $134K/yr
4+ years exp
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Responsibilities
Prepare, write, edit and review high-quality regulatory documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. This includes but not limited to 510(k)s, Pre-Market Approval (PMA) submissions and PMA Supplements, EU Technical Documentation Files and Global STEDs, Pre-Submission meeting packages to agencies, responses to regulatory agency requests, annual reports.
Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by the Global Regulatory Affairs (GRA) team members & functional area contributors.
Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
Work closely with team members on the strategic content of target documents.
Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRA team and/or authors/key opinion leaders. Ensure required documentation is obtained.
Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Resolve document content issues and questions arising during the writing process.
Assist in the design and implementation of tactical process improvements.
Qualification
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Required
BA, BS or equivalent experience in related field
4-8 years of experience
Excellent scientific writing skills
Proven experience performing literature reviews, analyzing data and communicating outputs
Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
Experience writing scientific documents for regulatory or journal submissions
Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
Demonstrated ability to build positive constructive relationships with cross-functional team members
Demonstrated high level of personal integrity, emotional intelligence, flexibility
Extensive knowledge of MDD, MDR and MEDDEV requirements
Experience creating and performing literature searches in Embase, PubMed and Google Scholar
Experience using Microsoft Word, Excel, PowerPoint. Strong data extraction and analysis skills
Proactive with a sense of urgency in managing job responsibilities
Self-motivated and able to work independently and with a minimum of supervision.
Analytical thinking and inquisitive mindset
Ability to work in a team environment and desire to develop good working relationships internally and externally
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (112)
2022 (131)
2021 (144)
2020 (126)
Funding
Current Stage
Public CompanyTotal Funding
$78M2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Donald M. Casey Jr.
Chief Executive Officer, Medical Segment
Jason Hollar
CEO
Recent News
2024-12-17
2024-12-17
Company data provided by crunchbase
