Job#: 3032939 Job Description: Technical WriterLocation: Lexington, Massachusetts (Remote)
Employment Type: Contract
Role OverviewAn opportunity is available for a Technical Writer to support a biopharma client. This role involves distilling technical information from multiple sources into well-crafted written deliverables that meet high-quality standards and align with client and health authority expectations. The position is a remote, contract role operating on EST hours.
Key Responsibilities- Distill technical information from various sources into concise written deliverables for regulatory submissions.
- Read and digest technical documentation related to product development, manufacturing, and testing.
- Mine technical documents for relevant data, synthesize information, and develop narratives, diagrams, tables, and figures.
- Organize information flow and write clear, concise technical content.
- Maintain awareness of pertinent health authority guidance, regulations, and trends.
- Ensure deliverables are high quality and generated according to agreed-upon timelines.
- Review and approve batch records, change controls, complaints, and investigations for compliance with cGMPs and ICH guidelines.
- Develop and author Standard Operating Procedures (SOPs).
- Support the submittal of regulatory filings and responses to agency inquiries.
- Facilitate collaboration across departments to meet regulatory timelines.
Required QualificationsExperience: A minimum of 2-3 years of experience as a technical writer is required, preferably from a biopharma industry background. Candidates must have Good Manufacturing Practice (GMP) experience and knowledge of documentation, quality, and technology transfers.
Preferred Qualifications- Experience with Veeva.
- Effective communication and organizational skills.
Compensation & BenefitsThe pay rate for this position is negotiable based upon experience. The anticipated pay rate is $40.00 per hour. The contract duration is for nine months or more.
This employer is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Apex uses a virtual recruiter as part of the application process. Click for more details.
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Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Everforth Apex uses a virtual recruiter as part of the application process. Click for more details.
Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
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