CMC Technical Writer
1 week ago
CMC Technical Writer - Contract - Wilmington, DE
Proclinical is working alongside a pharmaceutical company seeking a CMC Technical Writer to join their team in Wilmington, DE. In this role, you will be responsible for authoring and compiling CMC sections for global regulatory filings.
Primary Responsibilities:
The successful candidate will possess a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements. Additionally, work closely with cross-functional teams to ensure all CMC technical writing objectives are met.
The CMC Technical Writer's responsibilities will be:
- Manages the CMC regulatory writing strategy of high quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, CASs, NDAs Variations/Supplements and other relevant regulatory filings) for the assigned product(s) within defined timelines as per R&D and business objectives.
- Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
- Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related submissions
- Work closely with the Technical Operations team to ensure alignment and established priorities to meet corporate goals.
- Work collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP produced documentation excellence.
- Strong understanding of drug development process, pharmaceutical technology, drug manufacturing processes, analytical and GMP.
- CMC regulatory requirement knowledge for small molecules development through post approval and annual updates.
- US, Europe, Japan and Canada submissions experience and knowledge of guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- BS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant fields.
- 3-5 years of experience in authoring CMC sections of regulatory filings.
- Experience working closely with other departments such Process Chemistry, Analytical, PDMs, Reg. Ops and Regulatory Affairs.
- Demonstrate competency in clear and concise technical writing ability.
- Understand CMC manufacturing documentation requirements for small molecule manufactured products.
- Demonstrate track record of effective leadership including organization and prioritization of workload.
- Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
- Good decision making with strong judgment through collaboration and consideration of others point-of-view.
- Sound technical knowledge of process chemistry, analytical methods, and drug product.
- Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
- Must be knowledgeable and worked in biotech manufacturing related industry.
- Demonstrate excellent understanding of cGMP manufacturing execution.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raltez@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
-
wilmington, United States Proclinical Staffing Full timeCMC Technical Writer - Contract - Wilmington, DEProclinical is working alongside a pharmaceutical company seeking a CMC Technical Writer to join their team in Wilmington, DE. In this role, you will be responsible for authoring and compiling CMC sections for global regulatory filings. Primary Responsibilities:The successful candidate will possess a strong...
-
wilmington, United States Proclinical Staffing Full timeCMC Technical Writer - Contract - Wilmington, DEProclinical is working alongside a pharmaceutical company seeking a CMC Technical Writer to join their team in Wilmington, DE. In this role, you will be responsible for authoring and compiling CMC sections for global regulatory filings. Primary Responsibilities:The successful candidate will possess a strong...
-
Technical Writer
5 days ago
Wilmington, United States Fort Point LLC Full timeTECHNICAL WRITERSeeking a Technical Writer responsible for creating and maintaining technical documentation, system guides, safety protocols, user manuals and operational procedures. The Writer will collaborate with engineers, product managers and stakeholders to ensure complex technical information is communicated clearly and efficiently to technical and...
-
Technical Writer
1 week ago
Wilmington, United States HireResource Staffing Full timeAbout the CompanyA global leader in industrial gases and related technologies is seeking a skilled Technical Writer to join their team in Newport, DE (suburb of Wilmington DE). This is a fantastic contract-to-hire opportunity with a company that prioritizes safety and offers excellent benefits and career advancement potential to its full-time employees.About...
-
wilmington, United States Fort Point LLC Full timeTECHNICAL WRITERSeeking a Technical Writer responsible for creating and maintaining technical documentation, system guides, safety protocols, user manuals and operational procedures. The Writer will collaborate with engineers, product managers and stakeholders to ensure complex technical information is communicated clearly and efficiently to technical and...
-
wilmington, United States Fort Point LLC Full timeTECHNICAL WRITERSeeking a Technical Writer responsible for creating and maintaining technical documentation, system guides, safety protocols, user manuals and operational procedures. The Writer will collaborate with engineers, product managers and stakeholders to ensure complex technical information is communicated clearly and efficiently to technical and...
-
wilmington, United States HireResource Staffing Full timeAbout the CompanyA global leader in industrial gases and related technologies is seeking a skilled Technical Writer to join their team in Newport, DE (suburb of Wilmington DE). This is a fantastic contract-to-hire opportunity with a company that prioritizes safety and offers excellent benefits and career advancement potential to its full-time employees.About...
-
wilmington, United States HireResource Staffing Full timeAbout the CompanyA global leader in industrial gases and related technologies is seeking a skilled Technical Writer to join their team in Newport, DE (suburb of Wilmington DE). This is a fantastic contract-to-hire opportunity with a company that prioritizes safety and offers excellent benefits and career advancement potential to its full-time employees.About...
-
Oracle HCM Report Writers
2 months ago
Wilmington, United States Saxon Global Full timePosition: Oracle HCM Report Writers Location: Charlotte Hybrid, onsite 3x/week Contract Length: 3 month C2H Top Requirements: Oracle HCM experience Fluent in BI Publisher within Oracle OTBI reporting Nice to Haves Good personality, open to helping others PeopleSoft experience Day to Day Responsibilities/project specifics: This team is spearheading...
-
Technical Documentation Specialist
2 days ago
Wilmington, United States Meridian Technologies Full timeTechnical Documentation Specialist Newport, DE6-month W2 ContractJob Description: As a Technical Writer, you will be responsible for creating and maintaining technical documentation, including system guides, safety protocols, user manuals, and operational procedures. You will collaborate with engineers, product managers, and other stakeholders to ensure that...
-
wilmington, United States Meridian Technologies Full timeTechnical Documentation Specialist Newport, DE6-month W2 ContractJob Description: As a Technical Writer, you will be responsible for creating and maintaining technical documentation, including system guides, safety protocols, user manuals, and operational procedures. You will collaborate with engineers, product managers, and other stakeholders to ensure that...
-
QA Associate II/III
4 minutes ago
Wilmington, United States Alkermes Full timeThis position is located in Wilmington, OH. Position Summary Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include...
-
QA Associate I/II
4 weeks ago
Wilmington, United States Alkermes Full timeJob DescriptionThis position is located in Wilmington, OH.Position Summary Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also...
-
QA Associate II/III
4 weeks ago
Wilmington, United States Alkermes Full timeJob DescriptionThis position is located in Wilmington, OH.Position Summary Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also...
-
Marketing Coordinator
4 weeks ago
Wilmington, United States Kovalus Separation Solutions Full timeMarketing CoordinatorLocationWilmington, MAOnsite, Hybrid or Fully RemoteOnsiteStatusFull Time Reports ToSenior Marketing ManagerFLSA StatusExemptManagement PositionNoCompensation Min$ Compensation Max $ NOT open for visa sponsorship now or in the futurePosition Overview Reporting to the Senior Marketing Manager, the Marketing Coordinator will: Objectives...
-
Project Manager
4 months ago
Wilmington, United States Sobieski Services Full timeCommercial Project ManagerJ.F. Sobieski Mechanical Contractors, Inc. of Newark, DE is looking to hire a full-time Commercial Project Manager. Are you interested in a career with a growing company and supportive team? Would you like to work for a company that can offer you a combination of private-industry and rate jobs for more stable employment? If so,...
