Medical Writer - Regulatory Submissions
Medical Writer - Regulatory Submissions
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Job Description
Job Title: Medical Writer Regulatory Submissions
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Associate
What Medical Writing bring to Cardinal Health:
Fullservice product development and regulatory affairs consulting team that enables pharmaceutical medical and biotechnology companies obtain regulatory approval.
What is expected of you and others at this level:
Applies comprehensive knowledge and a thorough understanding of concepts principles and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures
Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently; receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as mentor to less experienced colleagues
The Regulatory Technical Writer (RTW) plays an important role in the Regulatory Affairs department supporting regulatory document writing to develop the global evidence base for company development programs. RTW is responsible for providing support to Global Regulatory Affairs (GRA) team for all submission needs. The Writer in this position will develop documents required to facilitate global regulatory programs by incorporating an understanding of the clinical development program relevant scientific literature and regulatory goals to drive scope and direction of datadriven summaries.
Responsibilities
Prepare write edit and review highquality 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 PreMarket Approval (PMA) submissions and PMA Supplements EU Technical Documentation Files and Global STEDs PreSubmission 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 and provide guidance 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.
Qualifications:
Bachelor's degree preferred or equivalent experience in related field
48 years of experience preferred
Excellent scientific writing skills
Experience working within a medical device or pharmaceutical organization in a Research & Development Scientific and Medical Affairs Clinical or Regulatory role.
Advanced knowledge of ISOCFR 820 EU MDD EU MDR FDA guidance documents and MEDDEV requirements
Experience performing literature searches in Embase PubMed and Google Scholar analyzing data and communicating outputs
Experience using Microsoft Word Excel PowerPoint. Strong data extraction and analysis skills
Experience writing scientific documents for regulatory or journal submissions
Experience presenting scientific/clinical evidence in a written and oral manner to crossfunctional teams.
Demonstrated ability to build positive constructive relationships with crossfunctional team members
Demonstrated high level of personal integrity emotional intelligence flexibility
Proactive with a sense of urgency in managing job responsibilities
Selfmotivated 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
Anticipated salary range: $93500 $ 136600
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and wellbeing.
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 longterm disability coverage
WorkLife resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close: 2/28/2025 *if interested in opportunity please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidate’s geographical location relevant education experience and skills and an evaluation of internal pay equity.
Candidates who are backtowork people with disabilities without a college degree and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin ancestry age physical or mental disability sex sexual orientation gender identity/expression pregnancy veteran status marital status creed status with regard to public assistance genetic status or any other status protected by federal state or local law.
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Employment Type
Full Time
