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Senior Medical Writer / Senior Project Manager, Clinical Evaluation
Abbott. Create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance documents, regulatory responses, and related documentation.
About the role
Key responsibilities & impact- Create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance documents, regulatory responses, and related documentation.
- Identify, evaluate, and summarize clinical evidence from clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations.
- Analyze results for product applications and submissions.
- Create, manage, or participate in deliverable timelines using project management tools.
- Communicate timelines, project risks, and mitigation strategies with cross-functional teams and medical writers.
- Interpret clinical, scientific, risk, and literature data for product applications.
- Participate in or lead regulatory responses to Notified Body questions.
- Facilitate communication and document exchange among internal stakeholders and external vendors.
- Provide strategic guidance on regulatory requirements related to clinical data and evaluations.
- Support internal and external audits, audit responses, root cause analysis, corrective and preventive actions, effectiveness monitoring, and quality metrics.
- Act independently on CER-related regulatory issues.
- Execute projects within budgetary guidelines.
Requirements
What you’ll need- A college degree (Bachelor’s) is required.
- Scientific/research background; training and degree in science, engineering, or medical fields.
- Understanding of research design, methodology, and statistics.
- Thorough understanding of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and related international harmonized standards and guidelines.
- Project management experience.
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
- Strong command of medical and surgical terminology.
- Ability to identify and adapt to shifting priorities and competing demands.
- Proven ability to deliver high-quality work within tight timelines.
- Highly-developed interpersonal skills and strong attention to detail.
- Able to travel as needed.
Benefits
Comp & perks- Career development with an international company where you can grow the career you dream of.
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan for qualifying employees in the next calendar year.
- Excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit toward a bachelor’s degree.
- Company recognition as a great place to work in dozens of countries worldwide.
- Equal Opportunity Employer.