Sr Scientist, Medical Writing

Cardinal Health

1d•Remote

About The Position

The Clinical Affairs function manages the clinical education, medical writing and communications, research, health care economics and patient safety while ensuring compliance with applicable regulatory and governing requirements for Cardinal Health products and services. Medical Writing is a specialized role that creates clear, accurate, and compliant documents to communicate complex clinical and scientific data. It supports regulatory submissions, clinical research, and scientific communications by interpreting data and producing protocols, reports, regulatory dossiers, presentations, congress abstracts, and peer-reviewed publications, all in alignment with industry and regulatory standards. Responsibilities: The Senior Medical Writer will plan and develop high quality clinical documents to support Cardinal Health devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Plans & Reports (PMS and PMCF) as required by EU regulations. Additional responsibilities include providing input for product development and post-market sustaining core teams. Additional responsibilities may be assigned. The Senior Medical Writer has medical writing and project management experience, 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, as well as other global requirements for clinical evaluation and PMS/PMCF. The Senior Medical Writer has the ability to lead cross-functional project teams. Qualifications 8-12 years of experience, preferred Bachelors in life science discipline; master’s degree or PhD preferred or equivalent work experience. Additional skills: Proven experience performing literature reviews, analyzing data and communicating outputs. Ability to provide thorough peer reviews of team members’ documents for completeness and correctness of data analysis & regulatory requirements. 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, along with other applicable global requirements for clinical evaluation and PMS/PMCF Experience creating and performing literature searches in Embase, PubMed and Google Scholar Excellent working knowledge of Microsoft Word, Excel, PowerPoint. Proficient in using EndNote or other reference manager software Strong data extraction and analysis skills Proactive with a sense of urgency in managing job responsibilities Recommends new practices, processes, metrics or models What is expected of you and others at this level Applies advanced knowledge and an 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 that 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

Requirements

8-12 years of experience, preferred
Bachelors in life science discipline; master’s degree or PhD preferred or equivalent work experience.
Proven experience performing literature reviews, analyzing data and communicating outputs.
Ability to provide thorough peer reviews of team members’ documents for completeness and correctness of data analysis & regulatory requirements.
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, along with other applicable global requirements for clinical evaluation and PMS/PMCF
Experience creating and performing literature searches in Embase, PubMed and Google Scholar
Excellent working knowledge of Microsoft Word, Excel, PowerPoint.
Proficient in using EndNote or other reference manager software
Strong data extraction and analysis skills
Proactive with a sense of urgency in managing job responsibilities
Recommends new practices, processes, metrics or models
Applies advanced knowledge and an 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 that 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

Responsibilities

The Senior Medical Writer will plan and develop high quality clinical documents to support Cardinal Health devices.
Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Plans & Reports (PMS and PMCF) as required by EU regulations.
Additional responsibilities include providing input for product development and post-market sustaining core teams.
Additional responsibilities may be assigned.

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