New!
Principal Medical Writer CSL
King of Prussia, PAToday
Highlights
Following this peak period, the workload is expected to gradually decrease, transitioning to a part-time level of support for the remainder of the engagement while document updates, reviews, approvals, and finalization activities are completed. The ideal candidate will have experience working in a regulated pharmaceutical, medical device, consumer health, or life sciences environment and possess strong document management skills using Microsoft Word and Adobe Acrobat.
Numbers & Facts
| Location | Fort Washington, PA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Technical Writer
Location: Fort Washington, PA 19034 (Hybrid)
Duration: 12+ months on W2 contract
Hours: Monday to Friday 8:30am to 5:00pm
Job description:
We are seeking a detail-oriented Technical Writer to support the development, revision, and management of manufacturing and engineering documentation within a GMP-regulated environment. This role will be responsible for converting complex engineering, validation, and technical documents into clear, compliant, and user-friendly Standard Operating Procedures (SOPs) and other controlled documentation.
The ideal candidate will have experience working in a regulated pharmaceutical, medical device, consumer health, or life sciences environment and possess strong document management skills using Microsoft Word and Adobe Acrobat. This position requires a significant on-site presence initially to build relationships with stakeholders, facilitate document reviews, and drive approvals and signatures through completion.
Key Responsibilities
The Technical Writer is needed to start immediately to become familiar with the site's equipment, systems, processes, and key stakeholders. The anticipated assignment duration is October 1, 2026 through October 1, 2027. Workload demand is expected to be highest during project initiation and throughout Q1 2027, as a significant volume of engineering and operational documentation will require conversion into SOPs and controlled documents. Following this peak period, the workload is expected to gradually decrease, transitioning to a part-time level of support for the remainder of the engagement while document updates, reviews, approvals, and finalization activities are completed.
Required Qualifications
Work Arrangement
Key Success Factors
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
Location: Fort Washington, PA 19034 (Hybrid)
Duration: 12+ months on W2 contract
Hours: Monday to Friday 8:30am to 5:00pm
Job description:
We are seeking a detail-oriented Technical Writer to support the development, revision, and management of manufacturing and engineering documentation within a GMP-regulated environment. This role will be responsible for converting complex engineering, validation, and technical documents into clear, compliant, and user-friendly Standard Operating Procedures (SOPs) and other controlled documentation.
The ideal candidate will have experience working in a regulated pharmaceutical, medical device, consumer health, or life sciences environment and possess strong document management skills using Microsoft Word and Adobe Acrobat. This position requires a significant on-site presence initially to build relationships with stakeholders, facilitate document reviews, and drive approvals and signatures through completion.
Key Responsibilities
- Review and interpret engineering, technical, validation, and operational documents.
- Transform technical content into clear, concise, and compliant SOPs, work instructions, and controlled documents.
- Collaborate with engineers, quality, validation, manufacturing, and cross-functional teams to gather and verify technical information.
- Ensure documentation aligns with GMP requirements, company standards, and document control procedures.
- Manage document review cycles, incorporating stakeholder feedback and maintaining version control.
- Coordinate approval workflows and actively facilitate the collection of required signatures and approvals.
- Maintain documentation accuracy, consistency, formatting, and traceability.
- Utilize Microsoft Word to develop and format professional documentation templates and final deliverables.
- Use Adobe Acrobat to review, edit, compile, and manage controlled PDF documentation.
- Support document archival, revision management, and document management system activities as required.
- Identify opportunities to improve documentation processes and standardization.
The Technical Writer is needed to start immediately to become familiar with the site's equipment, systems, processes, and key stakeholders. The anticipated assignment duration is October 1, 2026 through October 1, 2027. Workload demand is expected to be highest during project initiation and throughout Q1 2027, as a significant volume of engineering and operational documentation will require conversion into SOPs and controlled documents. Following this peak period, the workload is expected to gradually decrease, transitioning to a part-time level of support for the remainder of the engagement while document updates, reviews, approvals, and finalization activities are completed.
Required Qualifications
- Bachelor's degree in Technical Writing, English, Communications, Engineering, Life Sciences, or a related field, or equivalent experience.
- 2-4 years of technical writing experience in a GMP-regulated environment.
- Experience creating and editing SOPs, work instructions, controlled documents, or quality system documentation.
- Proficiency in Microsoft Word, including advanced formatting, styles, templates, tables, and document controls.
- Proficiency in Adobe Acrobat for document editing, review, and PDF management.
- Strong attention to detail with excellent proofreading and editing capabilities.
- Ability to interpret technical and engineering information and translate it into end-user documentation.
- Strong organizational, communication, and stakeholder management skills.
- Experience supporting pharmaceutical, consumer health, biotechnology, medical device, or manufacturing operations.
- Familiarity with document management systems and controlled document workflows.
- Experience working with Quality, Validation, Engineering, or Manufacturing teams.
- Knowledge of GMP documentation practices, data integrity principles, and compliance requirements.
Work Arrangement
- On-site in Fort Washington, PA during onboarding and initial engagement period to support stakeholder collaboration, document reviews, approvals, and signature collection.
- Opportunity for a hybrid schedule (1-2 remote days per week) once the individual has established working relationships, gained familiarity with documentation processes, and can operate independently.
Key Success Factors
- Ability to rapidly understand technical and engineering content.
- Strong ownership of documentation deliverables from draft through approval.
- Excellent collaboration skills and ability to drive documents to completion.
- Commitment to quality, compliance, and continuous improvement.
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.