Description:

Project management including planning, implementation, prioritization, meetings minutes and data entry/analysis on behalf of clients to keep projects on time, high quality and within budgets

Develop and execute on project requirements which may include: clinical research studies/clinical evaluation reports (CER), regulatory submissions, quality management systems, engineering reports

Ensuring quality by following internal and external SOPs, Work Instructions and

Forms/Templates for successful preparation of robust, high quality deliverable's

Read, analyze and implement regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines

Develop materials for on-line and in-person training (e.g. PowerPoint presentations)

Conduct literature searches and communicate scientific content in a clear, concise manner

No Medical

No Certs

No PPE

Skills:

Regulatory, Quality, Compliance, Medical Device

Additional Skills & Qualifications:

3+ years of clinical or regulatory affairs experience or clinical research 1+ years of medical writing or lit review experience

Master’s Degree or PhD (preferred) in a scientific discipline highly preferred

Nice to Have: CER writing experience.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.