Juniper Biosciences · 1 month ago
Senior Technical Writer
Bridgewater, NJ
Full-time
Onsite
Senior Level
5+ years expJuniper Biosciences is seeking a Senior Technical Writer to support the development and regulatory submissions for radiopharmaceutical products. The role involves authoring and maintaining high-quality documentation, ensuring compliance with GMP and regulatory standards, and collaborating with cross-functional teams.
ManufacturingMedicalPharmaceutical
Responsibilities
Draft, edit, and finalize technical documents including, but not limited to:
Analytical method development and validation protocols/reports
Equipment qualification and validation protocols/reports
Master batch records (MBRs) and associated controlled forms
Product development reports, technical summaries, and investigation reports
Stability protocols and reports
Specifications and test methods for raw materials, intermediates, and finished radiopharmaceutical products
Ensure documents are clear, concise, scientifically accurate, and consistent with internal templates and style guides
Translate complex technical data and experimental outcomes into well-structured, comprehensible documents for both technical and regulatory audiences
Ensure all documentation complies with GMP, ICH guidelines, and relevant regional regulations (e.g., FDA, EMA) for radiopharmaceuticals and sterile products
Incorporate appropriate data integrity and 21 CFR Part 11 principles into documentation practices
Support the preparation of CMC sections of regulatory submissions (e.g., IND/CTA, NDA/MAA, DMFs) by providing high-quality source documents and summaries
Work closely with Analytical Development, Product Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to gather data and technical content
Facilitate document review cycles, consolidating and addressing comments from multiple stakeholders
Participate in project meetings to understand technical strategies, timelines, and document needs
Prepare documents in alignment with document control procedures and manage revisions through the electronic quality management system (eQMS or DMS)
Own the lifecycle of key documents, ensuring timely updates following process changes, validation activities, or regulatory feedback
Support preparation for audits and inspections by ensuring documentation is complete, organized, and readily retrievable
Contribute to the development and refinement of templates, style guides, and best practices for technical documentation
Provide guidance and mentoring to junior writers or subject matter experts (SMEs) on effective technical writing and documentation standards
Identify opportunities to streamline documentation processes and improve consistency and quality
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Radiopharmacy, or a related scientific discipline
5–8+ years of experience in technical writing within the pharmaceutical, biotech, or radiopharmaceutical industry, preferably in a GMP environment
Demonstrated experience authoring analytical method validation protocols/reports, batch records, and other CMC/GMP documentation
Strong understanding of GMP, ICH Q guidelines, and regulatory expectations for sterile injectable or radiopharmaceutical products
Proven ability to interpret analytical and process data and present it clearly in written form
Excellent written and verbal communication skills in English, with strong attention to detail, organization, and consistency
Preferred
Experience in radiopharmaceuticals, nuclear medicine, or other short-lived isotope-based products
Familiarity with aseptic processing, cleanroom operations, and QC testing relevant to radiopharmaceuticals (e.g., sterility, endotoxin, radionuclidic purity, radiochemical purity)
Experience contributing to CMC sections for regulatory submissions (IND/CTA, NDA/MAA, ANDA, or equivalent)
Proficiency with electronic document management systems (eQMS/DMS) and standard office tools (Word, Excel, PowerPoint)
Company
Juniper Biosciences
Juniper Biosciences are at the forefront of transforming healthcare with revolutionary radiopharmaceuticals.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$40MKey Investors
NovaCapital
2025-12-01Seed· $40M
Leadership Team
Alex Agnoletto
CEO & Co-Founder
Indranil Nandi
COO and Co-Founder
Company data provided by crunchbase