Website The Hopkins MedTech
Together we can make a difference
The Hopkins MedTech Compliance helps medical device companies rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. HMC provides assistance in applying for EUA、 premarket notice 510K by FDA, CE mark by European Commission and MDR.
A career at HMC will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
Job Overview:
Responsible for the generation and development of documents relating to clinical evaluations and clinical investigations, and clinical study.
Responsibilities:
- Plan the clinical sections of global submissions
- Work with the manager to create timelines & resource plans for clinical submissions to implement for the team
- Advising managers in project specifications and resources assigned Review statistical analysis plans and case report forms
- Performing quality control and team reviews of clinical study reports & submissions written by fellow medical writers
- Work independently with the sponsor(s) for document planning, review, revision, and finalization.
- Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate and are to reflect a consensus among team members that is acceptable to all appropriate reviewers.
Background Experience:
- Bachelor’s degree in a health-related field or biochemistry with strong attention to detail and working knowledge of Excel and Word
- 1-2 years of experience in a pharmaceutical or CRO setting preferred
Contact
Please apply using the below function and send your CV/Resume directly. Please mention that you saw this JD on the SAPA website.