CMC Technical Writer

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.

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

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

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, short Fridays option, 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

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Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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