Principal Medical Writer

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-adjustments@gsk.com) to further discuss this today. #LI-GSK #LI-Hybrid In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD118,000 to CAD168,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our 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. Polish Salary Range / Polski przedział wynagrodzenia: PLN 229,500 to PLN 382,500The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. 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 candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniajÄ szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiÄ zujÄ cych polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjÄ tkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będÄ zapewnione zgodnie z przepisami prawa polskiego. MogÄ być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostanÄ przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogÄ być również widoczne, ponieważ na niektórych rynkach obowiÄ zujÄ przepisy dotyczÄ ce jawności wynagrodzeń, które wymagajÄ zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogÄ stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostanÄ omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty sÄ zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjÄ tkowych okolicznościach zgodnych z tymi kryteriami. 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. 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. 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 GSK's 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. 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 GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.