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

• 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 from 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.

The annual base salary in Poland for new hires in this position ranges from PLN 236,250 to PLN 393,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non‑discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.

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 GSK. In 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.

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.