Technical Architect
Location: Boston ( MA )
My client is a leading developer of software solutions for regulated industries (life sciences…etc). They have a very strong existing client base and have consistently over-achieved targets.
You must have experience in a Technical Architect role working with clinical Software/eClinical/regulatory submission/Drug Safety/EDC/IVRS/IVR/Ediary/Clinical Data/Quality Management/ERP/CRM/Supply Chain solutions)) Please email a word document of your resume to kmednick@kleinhersh.com
The Technical Architect will have a leading role in providing technical guidance on client project activities.
Key responsibilities include:
- Able to manage multiple concurrent regulatory projects and work closely with clients and technical lead to define strategies that meet the needs of the client.
- Provide and/or coordinate domain and strategy workshops, domain, and product training.
- Provide primary support on active project applications.
- Learn and support client internal protocols, SDLC, SOP’s and pilots of new emerging standards from regulatory (HL7) committees.
- Lead offshore development teams on project activities.
- General team administration efforts such as client security/access, invoicing, etc.
Essential Skills and Abilities:
- Must have 5-10 years architecture design .NET, and similar MS technologies experience with strong system architecture and integration knowledge.
- Must have experience with XML, databases; report building and the ability to create design documentation based on requirements.
- Must have experience working with clinical software organization ( ECTD, submissions, EDC, IVRS, etc…)
- Experience with regulatory standards (HL7 and others), 21 CFR Part 11 and FDA submissions such as clinical trial documents and SPL are a plus.
- MUST BE ABLE TO GET INTO THE OFFICE DAILY
Compensation:
- 80-120K Base + Bonus
- Excellent Benefits
Please email a word document of your resume to kmednick@kleinhersh.com In the body of the email, outline your Technical Architect experience and knowledge of eClinical software…
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