Lead Medical Document Specialist
Cardinal Health, Saint Paul, Minnesota, United States, 55130
Join the Clinical Affairs Team at Cardinal Health
The Clinical Affairs function is essential in driving clinical education, medical writing, communications, research, healthcare economics, and patient safety while ensuring rigorous compliance with all regulatory standards related to Cardinal Health's products and services.
As a Lead Medical Document Specialist, you will play a critical role in crafting clear, accurate, and compliance-focused documents that effectively convey complex clinical and scientific information. Your expertise will aid in regulatory submissions, clinical research, and scientific communications through the interpretation of data and the development of protocols, reports, regulatory dossiers, presentations, congress abstracts, and peer-reviewed publications, all while adhering to industry and regulatory standards.
Key Responsibilities:
Plan and develop high-quality clinical documents such as Clinical Evaluation Reports (CERs) and Post Market Plans & Reports (PMS and PMCF), ensuring compliance with EU regulations.
Contribute actively to product development and post-market support for core teams.
Lead cross-functional project teams, applying your medical writing and project management expertise effectively.
Qualifications:
A minimum of 8-12 years of relevant experience in medical writing or similar roles.
A Bachelor's degree in a life science discipline is required; a Master's degree or PhD is preferred, or equivalent work experience is acceptable.
Essential Skills:
Experience in conducting thorough literature reviews and data analysis, with the ability to communicate findings effectively.
Capability to provide comprehensive peer reviews to ensure regulatory compliance and data accuracy.
A background in medical devices or pharmaceuticals, particularly in Research & Development, Scientific Affairs, Clinical or Regulatory environments.
Proficiency in crafting scientific documents suitable for regulatory or journal submissions.
Demonstrated ability to present scientific or clinical evidence to diverse audiences.
Strong relationship-building skills to collaborate seamlessly with cross-functional teams.
High personal integrity paired with emotional intelligence.
Extensive knowledge of MDD, MDR, and MEDDEV regulations, along with global clinical evaluation requirements.
Competence in conducting literature searches on platforms such as Embase, PubMed, and Google Scholar.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software like EndNote.
Strong data extraction and analytical skills.
A proactive approach with a strong sense of urgency in all job responsibilities.
Ability to recommend and implement innovative practices and processes.
Expectations for this Role:
Utilize advanced knowledge to manage diverse projects effectively.
Contribute towards policy and procedure development to achieve specific organizational goals.
Lead complex projects that promise significant long-term impacts.
Propose solutions and methodologies for completing new projects independently.
Mentor less experienced colleagues to foster their professional growth.
Salary Range:
$123,400 - $149,855 Benefits:
At Cardinal Health, we offer a comprehensive range of benefits designed to promote health and well-being, including: Comprehensive medical, dental, and vision coverage. Paid time off for work-life balance. Health savings and flexible spending accounts. 401k savings plan to secure your financial future. Access to early wage payment options for convenience. Short- and long-term disability coverage for peace of mind. Work-life resources and paid parental leave support. Programs to encourage healthy lifestyle choices. The application window is anticipated to close on 2/6/2026. If you're interested in this exciting opportunity, we encourage you to apply promptly. Cardinal Health is an Equal Opportunity/Affirmative Action employer. We welcome and encourage applications from all qualified individuals regardless of race, religion, color, national origin, age, disability, gender identity or expression, sexual orientation, pregnancy, veteran status, marital status, or other statuses protected by law.
$123,400 - $149,855 Benefits:
At Cardinal Health, we offer a comprehensive range of benefits designed to promote health and well-being, including: Comprehensive medical, dental, and vision coverage. Paid time off for work-life balance. Health savings and flexible spending accounts. 401k savings plan to secure your financial future. Access to early wage payment options for convenience. Short- and long-term disability coverage for peace of mind. Work-life resources and paid parental leave support. Programs to encourage healthy lifestyle choices. The application window is anticipated to close on 2/6/2026. If you're interested in this exciting opportunity, we encourage you to apply promptly. Cardinal Health is an Equal Opportunity/Affirmative Action employer. We welcome and encourage applications from all qualified individuals regardless of race, religion, color, national origin, age, disability, gender identity or expression, sexual orientation, pregnancy, veteran status, marital status, or other statuses protected by law.