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100% Remote Role: CMC Project Manager |6+ months
Remote, Work from Home
Remote
Work from Home
00000
Date
: Jan-18-21
2021-01-18
2022-01-18
100% Remote Role: CMC Project Manager |6+ months
Remote, Work from Home
Jan-18-21
Work Authorization
US Citizen
GC
H1B
EAD (OPT/CPT/GC/H4)
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect
Rate/Salary ($)
:
Market
Duration
:
6 months
Sp. Area
:
Project, Product Management, Dev Ops
Sp. Skills
:
Project Manager - Functional
Permanent Direct Hire
Consulting / Contract
FULL_TIME, CONTRACTOR
Remote Work from Home
Required Skills
:
Project Manager, CMC, Lead, Regulatory Affairs, Trackwise, Merger and Acquisitions, Pharma
Preferred Skills
:
Domain
:
Pharmaceuticals
Work Authorization
US Citizen
GC
EAD (OPT/CPT/GC/H4)
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect
Rate/Salary ($)
:
Market
Duration
:
6 months
Sp. Area
:
Project, Product Management, Dev Ops
Sp. Skills
:
Project Manager - Functional
Permanent Direct Hire
Consulting / Contract
FULL_TIME, CONTRACTOR
Remote Work from Home
Required Skills
:
Project Manager, CMC, Lead, Regulatory Affairs, Trackwise, Merger and Acquisitions, Pharma
Preferred Skills
:
Domain
:
Pharmaceuticals
CBS llc
Scotch Plains, NJ
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Position: CMC Project Manager
Location: 100% Remote Role
Duration: 6+ month contract
Below is what candidates must have as a minimum for me to consider:
CMC Lead experience
10+ Regulatory Affairs experience in Pharma (not healthcare or finance – must be Pharma)
Extensive experience with Trackwise
Experience with Merger and Acquisitions (M&A) related to name and address changes
Description:
Client needs a resource to replace her current CMC lead for one of their programs.
Must be US Based (East Coast as will work east coast hours)
Experience in the post-approval space working to support CMC activities for small molecules and biologics (devices a plus) in US, EU and international markets
Worked with regulatory professionals in international markets
Experience with Merger and Acquisitions (M&A) related to name and address changes
At least 10+ years in regulatory affairs (associate director level)
Extensive experience with Trackwise change control, regulatory information managements systems and document management systems
Strong leadership and organization skills
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