FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
About the role
Key responsibilities & impact- This position reports to Manager/Sr. Manager, Medical Sciences and requires expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies
- The position mainly focuses on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs)
- Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document
- Develop and author responses to requests and questions on the clinical documentation from the regulatory authority
- Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies
- Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits
- Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools
Requirements
What you’ll need- Previous experience in the application of in-depth therapeutic and device knowledge for the development of clinical evaluation plans and reports
- Ability to identify critical information needs and identify roles / individuals to involve in the decision-making process within clinical evaluation assessment and report development
- Strong experience in conducting literature searches, and review and appraisal of scientific data.
- Expertise in clear and effective oral and written communication and in technical or scientific writing
- A minimum of 5 - 8 years of medical writing experience
- Excellent critical thinking and analytical skills
- A high level of attention to detail and accuracy
- Ability to work effectively with cross-functional teams
- Ability to manage multiple projects across numerous surgical disciplines
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Strong experience in protocol development, writing clinical sections of documents for regulatory submission and clinical evaluation report writing
- Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
- Consistent dedication and strong work-ethics to meet aggressive timelines and simultaneous management of multiple projects, when necessary.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical evaluation plansclinical evaluation reportsmedical writingliterature searchesscientific data appraisalprotocol developmentregulatory submissionstechnical writingdata analysisproject management
Soft Skills
critical thinkinganalytical skillsattention to detailcommunication skillsinterpersonal skillsorganizational skillsself-starter attitudeteam collaborationpresentation skillstime management