Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Sr Java Engineer - No C2C - USC/GC Only
$147K - $193K/yr
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Sr Java Engineer - No C2C - USC/GC Only
$147K - $193K/yr
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Sr Java Engineer - No C2C - USC/GC Only
Sunnyvale, CA · On-site
$147K - $193K/yr
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Sr Java Engineer - No C2C - USC/GC Only
Sunnyvale, CA · On-site
$147K - $193K/yr
Company Description ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects ...
Accounts Payable Specialist
Mission Viejo, CA · On-site
$22.75 - $29.25/hr
ccounts Payable Specialist 27271 Las Ramblas, Suite 210, Mission Viejo California 92691 (100% onsite) 6+ Month contract Must have: Role will be required to sit onsite in Mission Viejo at our Total ...
Accounts Payable Specialist
Mission Viejo, CA · On-site
$22.75 - $29.25/hr
ccounts Payable Specialist 27271 Las Ramblas, Suite 210, Mission Viejo California 92691 (100% onsite) 6+ Month contract Must have: Role will be required to sit onsite in Mission Viejo at our Total ...
Eyewear Specialist
San Jose, CA · On-site
$21 - $28.25/hr
Eyewear Specialist 2690 S. White Rd, Suite 255, San Jose California 95148 (100% onsite) 3 + Months contract Tuesday-Saturday: 9:00am to 5:30pm weekdays, 9:00am to 3:30pm on Saturdays, must have ...
Eyewear Specialist
San Jose, CA · On-site
$21 - $28.25/hr
Eyewear Specialist 2690 S. White Rd, Suite 255, San Jose California 95148 (100% onsite) 3 + Months contract Tuesday-Saturday: 9:00am to 5:30pm weekdays, 9:00am to 3:30pm on Saturdays, must have ...
Administrative - File Clerk I
Burbank, CA · On-site
$16.50 - $20.50/hr
Records Specialist 100 S California St Tower 1_B700, Burbank, CA 91505, USA (100% onsite) 4 months (Possibility for Extension) The Records Specialist will play a key role in the company's transition ...
Administrative - File Clerk I
Burbank, CA · On-site
$16.50 - $20.50/hr
Records Specialist 100 S California St Tower 1_B700, Burbank, CA 91505, USA (100% onsite) 4 months (Possibility for Extension) The Records Specialist will play a key role in the company's transition ...
Patient Care Coordinator
Santa Clara, CA · On-site
$20.50 - $26.75/hr
Patient Care Coordinator 2366 El Camino Real, Santa Clara, CA 95050, USA 6 Months contract Tuesday-Saturday: 9:00am to 5:30pm weekdays, 9:00am to 3:30pm on Saturdays Total Vision LLC is a group of ...
Patient Care Coordinator
Santa Clara, CA · On-site
$20.50 - $26.75/hr
Patient Care Coordinator 2366 El Camino Real, Santa Clara, CA 95050, USA 6 Months contract Tuesday-Saturday: 9:00am to 5:30pm weekdays, 9:00am to 3:30pm on Saturdays Total Vision LLC is a group of ...
Accounts Payable Specialist
Mission Viejo, CA · On-site
$22.75 - $29.25/hr
ccounts Payable Specialist 27271 Las Ramblas, Suite 210, Mission Viejo California 92691 (100% onsite) 6+ Month contract Must have: Role will be required to sit onsite in Mission Viejo at our Total ...
Accounts Payable Specialist
Mission Viejo, CA · On-site
$22.75 - $29.25/hr
ccounts Payable Specialist 27271 Las Ramblas, Suite 210, Mission Viejo California 92691 (100% onsite) 6+ Month contract Must have: Role will be required to sit onsite in Mission Viejo at our Total ...
Objectwin information
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CMC Regulatory Affairs Project Manager - Foster City, CA - Contract
Foster City, CA • On-site
Contractor
Re-posted 12 days ago
Job description
ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects and fulltime resource deployments. We serve our customers both nationally and globally.
Job Description
- Job Title: CMC Regulatory Affairs Project Manager
- Duration: 6 Months
- Job Location: 333 Lakeside Drive, Foster City, CA 94404
No Remote, No C2C - USC/GC holders only
Description: The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. The Project Manager will communicate with the cross functional CMC teams on small molecule and biologics submissions tracking. The Project Manager will attend CMC regulatory meetings and will be responsible for maintaining timelines, meeting minutes, action items, resource plans and other project documents.
Job Responsibilities:
- Facilitate communication of regulatory activities across CMC Sub-Teams and Senior Management
- Work on an improved tool for the regulatory department to track submissions
- Generate metrics on regulatory submissions and approvals across a wide-array of submission subtypes.
- Tracking of regulatory filings for clinical and commercial programs for all global markets
- Develop and manage detailed project timelines for regulatory activities
- Monitors project execution and adjusts plans
- Facilitates communication and documentation of regulatory activities across project teams and senior management
- Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
- Ensures project work complies with established practices, policies and processes
Qualifications
- Minimum 6 years of relevant experience and a BA or BS or 4 + years of relevant experience and a MS or MBA. Relevant experience consists of work in cross functional biopharmaceutical /pharmaceutical CMC development, GMP and regulatory affairs
- Excellent organizational skills, capable of setting priorities and delivering on commitments, while managing high workload
- Strong communication skills; written and verbal including oral presentation skills
- Experience in regulatory CMC project management is preferred
- In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint and other reporting/tracking tools
Additional Information
If this position be of interest to you, please contact me directly at 832-485-3662
About Objectwin Technology
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Houston, TX, US
Year founded
1997