Principal Medical Writer

Nazwa biura: Warsaw, Mississauga Milverton Drive
Posted Date: Dec

You will be a Principal Medical Writer who turns complex clinical and safety data into clear, regulatory-ready documents. You will work closely with clinical, safety, regulatory, statistics and programming colleagues. We value sound scientific judgement, practical problem solving and a collaborative mindset. This role offers growth through exposure to global submissions, process improvement and mentoring opportunities. Join us to help unite science, technology and talent to get ahead of disease together.

Key Responsibilities:

• Proven experience writing a wide range of clinical and regulatory documents (protocols, CSRs, CTD/NDA/MAA sections, IBs, briefing docs, regulatory responses).

• Work effectively in matrix teams to deliver high-quality, fit-for-purpose documents meeting GSK and global/local regulatory standards.

• Major contributor to planning and producing clinical dossiers for international regulatory submissions.

• Managed projects of increasing scope and complexity with demonstrated effectiveness.

• Understands cross-functional interdependencies (e.g., clinical pharmacology, biomarkers, health outcomes).

• Quickly assesses complex situations and implements practical scientific, operational, and submission solutions.

• Strong technical, statistical, and IT skills with ability to interpret complex clinical data.

• Synthesizes trends in text and statistics to organize clear content and messaging in reports and summaries.

• Reviews analysis and reporting plans, advising on table content and display; familiar with review tools and automation to speed document preparation.

• Mentors junior writers, adapts to changing priorities/therapeutic areas, and communicates effectively both orally and in writing.

Qualifications and Experience:

• PhD or equivalent expertise (e.g., a master's degree with relevant experience)

• 5 years clinical regulatory writing experience in the pharmaceutical industry.

• Possesses a good understanding of drug development.

• Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.

• Clear demonstration of understanding of how to interpret, describe and document clinical data.

• Possesses working knowledge of International Committee for Harmonization (ICH)/Good Clinical Practice (GCP).

• Possesses necessary computer skills and general computer literacy.

• Excellent English language skills (verbal and written).

What we offer:

• 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).

• Life insurance and pension plan.

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts.

• Sports cards (Multisport).

• Possibilities of development within the role and company's structure.

• Personalized learning approach (mentoring, online training' platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

• Supportive community and integration events.

• Modern office with creative rooms, fresh fruits everyday.

• Free car and bike parking, locker rooms and showers.

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (pl.recruitment-) to further discuss this today.

#LI-GSK #LI-Hybrid

The annual base salary in Poland for new hires in this position ranges from PLN 229,500 to PLN 382,500 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.
More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

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- to discuss your needs.

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 we're 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.

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