Average salary: $175,000 /yearly
More statsSearch Results: 26 vacancies
...Job Description
About This Role
This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include...
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Full time
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...Advanced degree with a focus on Chemistry, Manufacturing, and Controls.
Proven experience in scientific marketing, specifically in CMC.
In-depth knowledge of regulatory requirements and compliance standards in pharmaceutical, biotechnology, or related industries....
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Full time
...Description:
Note:
FULLY REMOTE
Job Details:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions...
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...overall project plans.
~Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
~Contributes to...
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For contractors
Flexible hours
...ability to work effectively in a fast-paced, collaborative environment.
Preferred/Desired:
Certified Management Consultant (CMC) certification is advantageous.
Experience working in Agile/Scrum development environments.
Salary Range:
The salary...
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...for clinical studies.
Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders.
Coordinates the procurement activities for comparator and NIMP and/or ancillary supplies.
Interprets...
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Permanent employment
Work experience placement
Self employment
Flexible hours
...to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (e.g., RA CMC, R&D Excellence, Clinical Operations, IT).
Responsibilities
Operate within and in support of the established RD data governance...
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Full time
...coordinator, research nurse, or research-related budget work preferred; AND Certified Professional Coder (CPC), Certified Medical Coder (CMC), or the ability to obtain an appropriate/approved coding certification within 18 months of employment/start date required.
Job...
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Holiday work
Work from home
...EXPERIENCE | EDUCATION:
High School Diploma or equivalent
And certification as a coder to include Certified Professional Coder (CPC), CMC, RHIT, RHIA, or Certified Coding Associate (CCA)
And three (3) years professional coding experience.
Knowledge of Correct Coding...
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Work from home
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Shift work
...(CPP) responsibilities, as well as hard copy pickup at company and mailings.
Point of contact between Regulatory Representatives/CMC and publishing teams
Ensuring Regulatory compliance with SOPs and Regulatory authorities
Provide support to RDA team members and...
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...or surgical procedures.
Must demonstrate the ability to make calls to obtain authorizations.
Coding certifications (CPC, CPMA, CMC, ART, RRA, RHIA, RHIT, CCS, CCA) and/or degrees (associate level, bachelor level, master level) preferred and may be considered in lieu...
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Work from home
Flexible hours
Shift work
...candidate:
someone with a mixed background not just lab but manufacturing and process development.
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective...
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Flexible hours
...Engineer’s license is required for this role.
**This position requires up to 100% travel, relocation is not required.**
There’s more to CMC than our steel products and the buildings, structures, and roads they go into. At CMC, it’s the people inside our recycling centers,...
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Relocation
...topics, particularly relating to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory-CMC function and corporate affairs as needed. In the short term, the individual in this role will also act as the US Reg Intel & Policy regional...
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Full time
Temporary work
Work alone
...Coder (COC) by American Academy of Professional Coders is required and must be maintained.
Existing CCF employees credentialed with CMC may be required to obtain CPC (or CCS-P, RHIT, or CCA) within 12 months.
Complexity of Work:
Coding assessment relevant to the...
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Hourly pay
Full time
Work experience placement
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Flexible hours
Shift work
...supervisory experience
And 5 years’ experience working in a clinical revenue cycle environment.
Coding certifications (CPC, CPMA, CMC, ART, RRA, RHIA, RHIT, CCS, CCA) and/or degrees (associate level, bachelor level, master level) preferred and may be considered in...
Work from home
Flexible hours
Shift work
...demonstrate a strong knowledge of medical claims recovery and/or collections rules and regulations.
Coding certifications (CPC, CPMA, CMC, ART, RRA, RHIA, RHIT, CCS, CCA) and/or degrees (associate level, bachelor level, master level) preferred and may be considered in...
Work from home
Flexible hours
Shift work
...for the development and life cycle management of combination products/devices. The candidate utilizes expertise to provide Regulatory CMC global regulatory strategy, support development activities and execute combination product submission deliverables.
This candidate...
Part time
Shift work
Day shift
...Engineer’s license is required for this role.
**This position requires up to 100% travel, relocation is not required.**
There’s more to CMC than our steel products and the buildings, structures, and roads they go into. At CMC, it’s the people inside our recycling centers,...
Local area
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Relocation
...Development.
Key Responsibilities:
~Together with SVP Product Development:
~develop and implement comprehensive plans to meet CMC needs that include drug substance, drug product and analytics
~plan and execute drug product manufacturing activities for the company...
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