CMC Technical Writer

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 peoples 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. Were uniting science technology and talent to get ahead of disease together.

Find out more:
Our approach to R&D

CMC Technical Writer

Responsible for incorporating regulatory strategies into regulatory submission documents and ensuring such documents are written and managed to team/project expectations and conform to the regulatory and company standards. Individual may be responsible either for a single product or multiple products.

Key Responsibilities include but are not limited to:

• 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

Why GSK

• 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 companys 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 to discuss your needs.

#LI-GSK

#LI-HYBRID

Why GSK
Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at