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Assistant Cmc Technical Writer Jobs

Head Of Cmc Jobs
By Enveda Biosciences At United States
Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards
Forecast and manage the supply of drug product for clinical trials
A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience
Excellent cross-functional leadership, team building, and communication skills
Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products
Hiring Manager Interview (45 minutes)
Data Analyst, Cmc Jobs
By EPM Scientific At United States
BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry
Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data
Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)
Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must
Drive and support data pipeline initiatives
Engage with the delivery of new process analytics tools cross-functionally
Assistant Writer Jobs
By Airrack At Los Angeles, CA, United States

About the Role: Writer’s work alongside our Head Writer, to take ideas from concept to fully-developed Video Outlines and Scripts. The Final Script is then passed off to production, and ultimately ...

Cmc Project Manager Jobs
By SSi People At United States
Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
Job Title: CMC Project Manager - Remote
Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables
Assist PD in driving decision making and communication
Pay Rate: $70/hr to $75/hr
Cmc Project Manager Jobs
By Integrated Resources, Inc ( IRI ) At Warren, NJ, United States
Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.
Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
Report on project progress, offer viable solutions and opportunities as they arise
Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.
Excellent interpersonal, communication, and presentation skills.
Strong leadership skills and executive presence; ability to positively influence outcomes.
Cmc Regulatory Technical Writer - Remote
By Synectics Inc. At United States
Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company
Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.
Ad hoc RA CMC support to line manager.
Good writing skills for technical writing
***Compensation is based on experience***
Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.
Senior Director, Cmc Jobs
By BioSpace At New York, NY, United States
Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product
Direct experience working with FDA, including knowledge of current ICH guidelines
In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management
Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs
Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development
Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development
Regulatory Cmc Jobs
By Discover International At United States
Strong project management skills, with the ability to manage multiple projects simultaneously.
Develop and implement CMC regulatory strategies for new product development and product lifecycle management.
Knowledge of regulatory requirements and guidelines, including FDA and EMA regulations
Manage and oversee the preparation and submission of regulatory documents, including INDs, BLAs, and amendments.
Provide guidance and support to cross-functional teams on regulatory CMC requirements and strategies.
Stay up to date with changes in regulatory requirements and industry trends that may impact product development and regulatory submissions.
Assistant Technical Writer - Entry Level In Nj
By Eurofins Lancaster Laboratories At Brunswick County, NC, United States
Experience with standard scientific protocols and general laboratory procedures.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Write technical summaries for reports based on raw data provided. Complete all other aspects of the report writing as required.
Proofread reports to insure that the data transferred from the raw data are technically and grammatically correct.
Assist in the preparation of protocols, SOP’s and other technical documents.
A Bachelor of Science degree in biology, chemistry or equivalent is desired.
Radiology Engineering Buyer Atrium Health Cmc
By Atrium Health At , Charlotte, 28203, Nc
Bachelor’s Degree or 5 years purchasing management experience required. Medical supply purchasing preferred.
Assists management with 3rd party vendor evaluation and selection for parts and service purchasing.
Prefers knowledge of Mainsprings database for proper recording of purchased parts in work orders. Require previous experience working in database programs.
Maintains knowledge of Radiology equipment and schematics for adequate procurement of components.
Gathers feedback from our engineers to ensure that parts are meeting all their requirements.
Maintains knowledge and understanding of implementing inventory control systems.
Rn Administrative Supervisor - Cmc - Weekends
By Atrium Health At , Charlotte, 28203, Nc

Assists with appropriate utilization of resources to meet patient care needs

Staff Psychiatrist Out Pat-Cmc
By UTMB Health At , Dallas, 75241, Tx

Eligible for Board Certification in Psychiatry.

Current full/unrestricted Texas Medical License.

Director/Sr Director Cmc, Wuxi Vaccines
By WuXi Biologics At United States
Good knowledge in CMC strategy, risk and resource management, regulatory requirements and ICH guidelines;
Strategic view and leadership abilities as well as hands-on problem solving skills. Experience in managing projects is required;
Get buy-in and sponsorship from Management to ensure project success;
Knowledge of FDA, EU, WHO, NMPA and PIC/S GMP requirements;
Extensive working experience and knowledge in vaccines analytical and process development, business development, manufacturing and scale-up, quality and regulatory;
Act as technical leader in client interaction and internal function discussion during proposal preparation to enhance current service offerings;
Chief Maintenance Engineer-Cmc Hotels
By CMC Hotels At , Cary, 27518, Nc
We offer our associates an array of benefits, to include:
Competitive Salary based on experience
Ability to organize and manage multiple priorities
Experience installing and troubleshooting electrical switches, operating boilers and HVAC units, also to include drywall repair, plumbing repairs, etc.
Previous Hotel/Apartment/Strip mall, Maintenance experience a must
4 + years Hotel Maintenance experience with a minimum 2 years experience in full service