Average salary: $167,500 /yearly
More statsSearch Results: 34 vacancies
$150k - $170k
...values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading!
Role Summary
We are seeking a Sr. CMC Project Manager to join the Technical Operations team at Apogee. This role is responsible for handling all CMC related documentation,...
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Remote job
Flexible hours
...The Global Regulatory & CMC Lead is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory representative on the respective program teams. This includes Karyopharm’s key clinical programs, international...
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Holiday work
Full time
Immediate start
...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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...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 range...
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Local area
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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
$185k - $201k
...Substance/Drug Product/Bottling/Labeling for conformance with cGMPs, Quality Control to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory...
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Holiday work
Contract work
Temporary work
Work experience placement
Local area
...goals. You will work cross-functionally internally and externally with medical/clinical, pre-clinical, biostatistics, data management, CMC/clinical supplies, regulatory and commercial functions to ensure that clinical program and protocol design, including critical...
Suggested
Full time
Relief
$130k - $155k
...Responsibilities:
Gather information, format, and assemble regulatory submissions, particularly IND Chemistry Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriate
Perform technical editing (i.e., references, internal/external linking,...
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Holiday work
Local area
...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
$265k - $280k
...maintain risk registry, and develop/monitor actionable mitigation and contingency plans across all functions (ie: clinical, non-clinical, CMC, regulatory).
Monitor and track progress against set goals for program delivery.
Lead decision making discussions, capture and...
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Remote job
Relocation bonus
Flexible hours
...Our product portfolio consists of customized air core inductors made of round or flat wire, bar core inductors, storage inductors, CMC inductors, transformers, as well as ferrite cores. The customized designs are 100% tailored to the requirements of our customers and...
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Temporary work
Flexible hours
...least one (1) year in a lead capacity.
Certified Professional Coder (CPC), Certified Coding Specialist – Physician-based (CCS-P), CMC, RHIT, RHIA, or Certified Coding Specialist (CCS) preferred. Knowledge of Correct Coding Initiatives (CCI), Epic electronic health record...
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Contract work
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Work from home
Flexible hours
Shift work
Monday to Friday
...that include, but are not limited to, medical, statistics, programming, trial management, data management, regulatory, nonclinical, CMC, and project management. The successful candidate will have strong analytical skills, high quality standards, and is committed to meet...
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Fixed term contract
Remote job
Flexible hours
Shift work
...EDUCATION:
REQUIRED:
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.
PREFERRED:
Knowledge of...
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Work from home
Flexible hours
Shift work
...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
...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...
Full time
...cell-based methods to support QC method lifecycle.
Tracking project status and communicating to cross-functional teams including QC, CMC, and Quality.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
Bachelor’s or Master’s degree in Biology,...
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Contract 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...
Remote job
Flexible hours
$285k - $310k
...Quality Assurance and Manufacturing
Partner with late-stage discovery and accelerate our development candidates into IND-enabling CMC development
Develop and execute strategies for moving therapeutic candidates from early to late stage and commercial product development...
Remote job
Contract work
Flexible hours
