Merck · 17 hours ago
Technical Writer/Scientific - II
Merck is seeking a skilled Technical Writer to join their multidisciplinary team focused on the commercialization of biopharmaceutical procedures. The role involves authoring and reviewing Analytical Test Methods and regulatory filing documents to ensure QC testing procedures meet stringent commercial standards.
Responsibilities
Author and critically review technical documents, specifically focused on Analytical Test Methods and Regulatory Filing sections
Create and revise documentation that is strictly compliant with current Good Manufacturing Practices (cGMP)
Perform Second Person Review or Second Scientist Review to ensure data integrity and technical accuracy
Collaborate with method experts and key stakeholders to translate technical processes into clear, executable procedures
Support regulatory submission groups by drafting documents that meet ICH and USP guidelines
Lead or participate in group initiatives to develop document standards and templates for the organization
Manage document workflows within electronic repository systems to ensure version control and timely approvals
Maintain a proactive, service-oriented mindset while working across cross-functional teams to meet project milestones
Qualification
Required
Minimum of a BS/BA in Life Sciences or Engineering is required
At least 2 years of experience working in a cGMP laboratory environment, specifically within the biopharmaceutical, biologics, or vaccine industries
Proven experience in technical operations, quality control writing, or commercialization documentation
Strong skills in the MS Office suite and experience with laboratory data management or document repository systems
Demonstrated ability to work independently, excellent interpersonal skills, and a high level of detail orientation
Preferred
Master's degree or PhD is preferred
Familiarity with analytical method validation and transfer according to ICH and USP guidelines is preferred
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Recent News
2026-02-06
2026-02-05
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