CMC Technical Writer

Warsaw, Poznan Grunwaldzka

Posted Date: Nov 4 2025

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Key Responsibilities

• Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects
• Collaborate with CMC regulatory lead to provide regulatory support for assigned projects
• Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post‑approval supplements and variations
• Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)
• Prepare and coordinate the review and approval of submission‑ready documents
• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
• Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check
• Work collaboratively with CMC regulatory colleagues and SMEs to interpret and summarize complex data

Required Skills and Qualifications

• Degree in life sciences or related scientific discipline
• Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products
• Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)
• Thorough understanding of change management processes and regulatory requirements.
• Strong problem solving and diplomacy skills.
• Excellent project management skills

Benefits

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Hybrid working model (where GSK site are in Poland)
• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, health & well‑being activities)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

Inclusion at GSK

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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Seniority level

• Not Applicable

Employment type

• Full‑time

Job function

• Marketing, Public Relations, and Writing/Editing

Industries

• Pharmaceutical Manufacturing

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