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Senior Medical Writer
- Boston, Massachusetts
- Job Type
- 12 Sep 2022
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The key responsibilities for Senior Medical Writer are:
* Creation and maintenance of regulatory documents related to clinical data of products (CER, SSCP, PMCF) in liaison with other departments
* Plan and execute structured literature searches, identify and analyze relevant clinical data
* Write Clinical Evaluation plans and reports in compliance with applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG)
* Write PMCF plans, protocols and reports; work with Project Management to manage cross-functional stakeholders and review and integrate their input into PMCF plans and reports
* Write study protocols, safety plans and reports in liaison with Medical and Regulatory Affairs
* Support Medical Affairs and Regulatory Affairs in development and execution of regulatory strategies
* Manage vendors; Plan and coordinate vendor activities
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The successful Senior Medical Writer will have:
* Bachelor or Master of Science (required)
* Minimum of 7-10 years of experience in in the medical device/pharmaceutical industry
* Minimum years of experience in medical/scientific writing
* Manage numerous external vendors and contingent workers (supervisory role)
* Clear, concise scientific style of writing; attention to detail to provide high-quality results
* Affinity to scientific literature and data analyses using state-of-art information technology
Our client has a comprehensive portfolio of devices, information management, and consulting services offers blood management solutions for each facet of the blood supply chain.
If you are interested in this opportunity, please apply directly and all qualified candidates will be contacted. This role offers a competitive salary and bonus structure that is commensurate with current salary and experience.
The client is an equal opportunity employer.
- Job Reference: 710312334-2
- Date Posted: 12 September 2022
- Recruiter: Michael Page
- Location: Boston, Massachusetts
- Salary: On Application
- Sector: Science & Technology
- Job Type: Permanent