... written by Regulatory prior to submission to ensure content is CTD compliant. Managing associated submission RFls within timeframe. Quality Compliance owner for Technical Transfers projects ...
... written by Regulatory prior to submission to ensure content is CTD compliant. Managing associated submission RFls within timeframe. Quality Compliance owner for Technical Transfers projects ...
At The Dyer Partnership, our work goes far beyond engineering drawings and technical reports. It ... Strong communication and report writing skills. What We Offer: * Competitive salary, DOE. * Health ...
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At The Dyer Partnership, our work goes far beyond engineering drawings and technical reports. It ... Strong communication and report writing skills. What We Offer: * Competitive salary, DOE. * Health ...
At The Dyer Partnership, our work goes far beyond engineering drawings and technical reports. It ... Strong communication and report writing skills. What We Offer: * Competitive salary, DOE * Health ...
Quick apply
At The Dyer Partnership, our work goes far beyond engineering drawings and technical reports. It ... Strong communication and report writing skills. What We Offer: * Competitive salary, DOE * Health ...
Engineering Administrative Specialist
Roseburg, OR · On-site
$44K - $60K/yr
Strong oral and written communication skills. Education: * Associate's or Bachelor's degree in business administration, engineering, or related technical field preferred. * 1+ years experience in ...
Quick apply
Engineering Administrative Specialist
Roseburg, OR · On-site
$44K - $60K/yr
Strong oral and written communication skills. Education: * Associate's or Bachelor's degree in business administration, engineering, or related technical field preferred. * 1+ years experience in ...
Senior Executive, Compliance
OR · On-site +1
... written by Regulatory prior to submission to ensure content is CTD compliant. • Managing associated submission RFls within timeframe. • Quality Compliance owner for Technical Transfers projects ...
Senior Executive, Compliance
OR · On-site +1
... written by Regulatory prior to submission to ensure content is CTD compliant. • Managing associated submission RFls within timeframe. • Quality Compliance owner for Technical Transfers projects ...
Systems Architect I
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$227K/yr
You have strong verbal and written communication skills, with the ability to engage both technical and non-technical stakeholders * You can clearly document technical decisions using visuals ...
Systems Architect I
OR · Hybrid
$227K/yr
You have strong verbal and written communication skills, with the ability to engage both technical and non-technical stakeholders * You can clearly document technical decisions using visuals ...
Nuclear Engineer
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... technical teams; high expectations for attention to detail, judgment, and written and oral communication. Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of ...
Nuclear Engineer
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... technical teams; high expectations for attention to detail, judgment, and written and oral communication. Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of ...
Nuclear Engineer
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... technical teams; high expectations for attention to detail, judgment, and written and oral communication. Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of ...
Nuclear Engineer
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... technical teams; high expectations for attention to detail, judgment, and written and oral communication. Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of ...
Nuclear Engineer
$97K - $116K/yr
... technical teams; high expectations for attention to detail, judgment, and written and oral communication. Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of ...
Fieldglass, VNDLY, Beeline Integration Architect
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
Quick apply
Fieldglass, VNDLY, Beeline Integration Architect
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
Fieldglass, VNDLY, Beeline Integration Architect
OR · On-site
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
Fieldglass, VNDLY, Beeline Integration Architect
OR · On-site
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
Fieldglass, VNDLY, Beeline Integration Architect
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
Fieldglass, VNDLY, Beeline Integration Architect
$66.25 - $85.50/hr
... to write scripts and basic JSON/cXML format statements * Coordinates & provides input to technology and data staging (functional and technical) * Manages technical documentation creation, analysis ...
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$105K - $115K/yr
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Clinical Specialist (Orthotics - PCS)
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$105K - $115K/yr
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Federal Solution Engineer
OR · Remote
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$59 - $77.75/hr
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$136K - $142K/yr
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Digital Model / BIM Automation Developer -Kiewit Nuclear Solutions
OR · Remote
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This position provides technical leadership, project management, and mentorship while coordinating ... Strong written and verbal communication skills (including public-facing communication). Preferred:
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This position provides technical leadership, project management, and mentorship while coordinating ... Strong written and verbal communication skills (including public-facing communication). Preferred:
This position provides technical leadership, project management, and mentorship while coordinating ... Strong written and verbal communication skills (including public-facing communication). Preferred:
Quick apply
This position provides technical leadership, project management, and mentorship while coordinating ... Strong written and verbal communication skills (including public-facing communication). Preferred:
Excellent presentation, speaking, and writing skills with the ability to effectively communicate complex technical concepts to a broad range of audiences, including senior DoW officials.
Excellent presentation, speaking, and writing skills with the ability to effectively communicate complex technical concepts to a broad range of audiences, including senior DoW officials.
Principal Architect
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Support the team in writing technical specifications for the high-level portal architecture. Project & Program Management * Lead cross-functional initiatives from concept to delivery, ensuring ...
Principal Architect
OR · Remote
Support the team in writing technical specifications for the high-level portal architecture. Project & Program Management * Lead cross-functional initiatives from concept to delivery, ensuring ...
Technical Writing information
See Remote, OR salary details
$13.69 - $18.45
2% of jobs
$18.45 - $23.21
7% of jobs
$23.21 - $27.97
12% of jobs
$29.08 is the 25th percentile. Wages below this are outliers.
$27.97 - $32.73
16% of jobs
The median wage is $36.29 / hr.
$32.73 - $37.48
17% of jobs
$37.48 - $42.24
14% of jobs
$45.34 is the 75th percentile. Wages above this are outliers.
$42.24 - $47
11% of jobs
$47 - $51.76
10% of jobs
$51.76 - $56.52
5% of jobs
$56.52 - $61.28
3% of jobs
$61.28 - $66.04
3% of jobs
$13
$38
$66
How much do technical writing jobs pay per hour?
What are the key skills and qualifications needed to thrive as a Technical Writer, and why are they important?
Is AI taking over technical writing?
What is technical writing?
What are some common challenges technical writers face when collaborating with subject matter experts (SMEs)?
What do you do as a technical writer?
Is technical writer in demand?
How much money can you make as a technical writer?
What is the difference between Technical Writing vs Technical Documentation?
| Aspect | Technical Writing | Technical Documentation |
|---|---|---|
| Primary Focus | Creating clear, concise written content for various audiences | Developing detailed technical materials, manuals, and guides |
| Work Environment | Corporate, tech companies, consulting firms | Engineering teams, product development, IT departments |
| Required Skills | Writing, editing, communication, basic technical knowledge | Technical knowledge, writing, documentation tools |
Technical Writing and Technical Documentation are closely related roles. Technical Writing focuses on producing user-friendly content for diverse audiences, while Technical Documentation emphasizes creating detailed technical manuals and guides for engineers and technical staff. Both roles require strong writing skills and technical understanding, but their end goals and audiences differ.
Other
Posted 28 days ago
Job description
Main purpose of role:
- The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with current Marketing Authorization information and ensuring that CMOs comply with this information and Pharmacopoeial requirements.
- This role ensures compliance with registered information and Pharmacopoeial requirements by:
Ensuring license non-compliances as identified through already established Compliance processes are addressed within a pre-defined timeframe based on risk.
Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission.
The Senior Executive- Quality Compliance has a cross-functional role working closely with Regulatory Affairs, Technical, Operations projects, other Quality functions and CMOs to ensure the above is achieved.
Key responsibilities (In Points):
Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines.
Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information.
Writing supporting Quality related submission documents, as necessary.
Managing workload appropriately with the ability to re-prioritize rapidly as necessary.
Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized.
Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant.
Managing associated submission RFls within timeframe.
Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines.
Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships.
Quality Compliance SME for Projects owned by both the Compliance team and other departments.
Document Number - Q-FO-1221 Version - 1.0
Page 2 of 2
Requirement Essential Desirable Qualifications:
1.Minimum Degree in Chemistry, Pharmacy or Microbiology
2.Post Graduate Qualification in relevant scientific discipline
Experience & Competences:
3.Minimum 5 years' experience of working in a similar role within a pharmaceutical industry
4.Extensive GxP knowledge across all dosage forms
5.Experience in authoring Module 3 in CTD format
6.Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose
7.Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions
8.Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI)
9.Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements
10.Capable of working to deadlines & remain calm under pressure
11.Proven ability to organize and prioritize multiple tasks
12.Ability to work effectively as part of a team and cross functionally
Knowledge & Skills:
13.Knowledge of regulatory guidance for variations
14.Excellent communication skills, both oral and written, to include senior management in third party suppliers
15.Sound working knowledge of all Microsoft Office applications
16.Well organized with logical & methodical approach to work
17.Sound problem-solving skills
18.Good organization & time management skills
Personal Qualities:
19.Professional, methodical approach to work with 'can-do' attitude
20.Even tempered, positive persona, approachable
21.Helpful & flexible with strong team spirit
22.Cultural leader for core values