Job Description

The Senior Technical Writer will be responsible for authoring, reviewing, and maintaining high-quality CMC and GMP documentation to support development, manufacturing, testing, and regulatory submissions for radiopharmaceutical products. This role is heavily focused on analytical methods, validation protocols/reports, batch records, and product development reports, ensuring that all documentation is scientifically sound, inspection-ready, and aligned with applicable regulatory and quality standards (e.g., GMP, ICH, FDA, EMA).

The ideal candidate combines strong technical understanding of radiopharmaceuticals or sterile drug products with excellent writing, data interpretation, and cross-functional collaboration skills.

Key Responsibilities

1. Technical Document Authoring & Review

· 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.

2. GMP & Regulatory Compliance

· 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.

3. Cross-Functional Collaboration

· 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.

4. Document Control & Lifecycle Management

· 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.

5. Continuous Improvement

· 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.

Qualifications

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).

Key Competencies

· Strong scientific and technical literacy, with the ability to quickly understand new processes and analytical methods.

· Exceptional technical writing and editing skills, with a focus on clarity, structure, and data integrity.

· High level of ownership, accountability, and ability to manage multiple documents and deadlines in parallel.

· Collaborative mindset with the ability to work effectively across multi-disciplinary teams.

· Detail-oriented, quality-focused, and comfortable working in a regulated environment.

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