Pyramid Consulting, Inc · 1 month ago
Technical Writer II
United States
Contract
Remote
Senior Level
$50/hr - $56/hr
5+ years expPyramid Consulting, Inc. is a leading Healthcare Industry provider, and they are seeking a Technical Writer II for a contract opportunity. The role involves developing and authoring regulatory documents related to chemistry, manufacturing, and controls (CMC) while ensuring compliance with regulatory guidelines and collaborating with key stakeholders.
ConsultingInformation TechnologyLegalProfessional ServicesSoftwareStaffing Agency
Responsibilities
The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines
This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports
Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs
Following regulatory guidelines, source documentation, and client templates
Collaborating and coordinating with key stakeholders across the GBU’s,contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
Avoiding unsolicited regulatory burden
Supporting the development of regulatory risk mitigation strategies
Maintaining up-to-date knowledge of client ways of working, SOPs, and CMCregulations and guidelines
The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:
Supporting the planning and preparation of timelines
Qualification
Required
Key skills; Regulatory submission, Technical Writer/ Regulatory Writing, Authoring
CMC Regulatory Authoring
Regulatory submissions
Bachelor Degree
BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field)
Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3)
The candidate must have at least 5 years' experience in the pharmaceutical industry
Experience with MS suite of software applications is expected
Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team
The candidate needs very little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated
Knowledge of US pharmaceutical Regulations is essential
Preferred
A background in pharmaceutical manufacturing or quality control/quality assurance is a plus
Expertise with document management systems such as Veeva or Documentum is a plus
A working knowledge of cGMP's is desired
Medical device experience is a plus
Exposure to ex-US Regulations is desired, but not mandatory
Benefits
Health insurance (medical, dental, vision)
401(k) plan
Paid sick leave (depending on work location)
Company
Pyramid Consulting, Inc
Pyramid Consulting, a global leader in workforce and technology solutions, empowers individuals and organizations to transform and thrive in the most challenging and competitive markets.
5001-10000 employees
H1B Sponsorship
Pyramid Consulting, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (178)
2024 (112)
2023 (95)
2022 (62)
2021 (50)
2020 (117)
Funding
Current Stage
Late StageLeadership Team
Ramesh Maturu
President and Co-Founder
Manish Kaushik
Chief Financial Officer
Recent News
2025-08-18
Company data provided by crunchbase