Cardinal Health • Frankfort, KY 40621
Job #2692514329
What Medical Writing contributes to Cardinal Health
The Medical Writing Project Manager is a member of the Medical Affairs team, within in Global Medical Products, and is responsible for the planning, development, writing and reviewing Post Market Surveillance Plans and Clinical Evaluation Reports for the medical devices.
The Project Manager has medical writing experience, strong project management expertise, a thorough understanding of research methodology and the ability to develop high-quality clinical documents. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required. The Project Manager has the ability to lead cross-functional project teams.
Responsibilities
Develop and manage PMS and CER project plans, timelines, and project tracking tools.
Manage contract writers including maintaining contractor agreements, CVs, training records, ensuing timelines are adhered to and providing feedback on the prepared documents
Write PMS plans using the analysis done in the CER
Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature and state of the art to support assigned product lines.
Apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures
Collect, maintain, archive and retrieve all documents necessary to ensure compliance with SOPs and regulations
Participate in audits
Qualifications
Bachelors in a relevant discipline required. Master's degree or PhD highly preferred.
3-5 years related medical device experience preferred
Clinical background, or extensive clinical research experience in medical device or pharmaceutical industry
Experience writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR
Excellent written communication skills
Experience managing medical writing projects
Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders and auditors
Demonstrated high level of personal integrity, emotional intelligence, flexibility
Experience creating and performing literature searches in Embase, PubMed and Google Scholar
Experience using Microsoft Word, Excel, PowerPoint.
Analytical thinking and inquisitive mindset
Ability and desire to develop good working relationships internally and externally.
What is expected of you and others at this level
Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
Participates in the development of policies and procedures to achieve specific goals
Recommends new practices, processes, metrics, or models
Works on or may lead complex projects of large scope
Projects may have significant and long-term impact
Provides solutions which may set precedent
Independently determines method for completion of new projects
Receives guidance on overall project objectives
Acts as a mentor to less experienced colleagues
Anticipated salary range: $102,000 - $145,700
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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
Application window anticipated to close: 7/2/2024 *if interested in opportunity, please submit application as soon as possible.
Candidates who are back-to-work, 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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