What Medical Writing contributes to Cardinal HealthThe Medical Writer is a member of the Medical Segment Clinical Affairs team and is responsible for researching, creating, editing and coordinating the production of clinical documents; with a focus on Clinical Evaluation Reports and Post Market Surveillance Plans and reports required for CE marked devices.The Medical Writer will plan and develop high quality clinical documents to support Medical Segment devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Surveillance Plans and Reports as required by EU regulations and other global regulations. Additional responsibilities include providing input to product development and post-market sustaining core teams. Additional responsibilities may be assigned.The 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.Responsibilities
Write clinical evaluation reports (CERs) and post market surveillance summaries
Perform gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements.
Work with internal teams to gain cross-functional inputs and approvals
Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
Develop and manage CER project plans and timelines.
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 support assigned product lines.
Consistently apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures
Assist in development of processes Collect and maintain all documents necessary to ensure compliance with SOP
Qualifications
Bachelors in a relevant discipline required. Master's degree or PhD preferred
Minimum 2 years medical writing experience preferred
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 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 Knowledge of MDD, MDR and MEDDEV requirements
Proficient scientific writing skills
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.
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 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
Anticipated salary range : 93,500 - $133,600Bonus eligible : NoBenefits : 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: 12/4/2024 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.#LI-MP1Candidates 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.To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)