Informacje o stanowisku

Site Name: Poznan Business Garden, Mississauga Milverton Drive, Warsaw Rzymowskiego 53

Posted Date: Jan 8 2025

Principal Medical Writer

The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.

Specific Requirements for this Position:

• 7+ years of advanced regulatory medical writing experience (protocol, CSRs, briefing books, summary modules); prior experience in oncology and understanding of clinical pharmacology concepts will be an advantage.
• Advanced understanding of and ability to apply statistical and regulatory concepts needed to independently write complex regulatory documents without the guidance of a supervisor.
• Proven expertise in completion of multiple-document projects including functioning as the lead medical writer (e.g. Lead Writer for a CTD submission dossier with authoring and oversight activities across several Module 2 documents).

Key Responsibilities include, but are not limited to:

• Writing clinical regulatory documents including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Working in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional, and/or local regulatory requirements.
• Contributing significantly in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Managing projects of increasing scope and complexity effectively.
• Understanding the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Quickly assessing complex situations and implementing effective plans for solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assessing trends and patterns in text and statistical data, and effectively organizing content and messages in clinical reports and summary documents.
• Reviewing reporting and analysis plans and providing critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Adjusting behaviors and priorities based on a changing environment.
• Effectiveness in both oral and written communications.

Required Qualifications:

• PhD or relevant working experience within the life sciences space.
• Clinical regulatory writing experience in the pharmaceutical industry.
• Demonstration of leadership.
• Experience in multicultural settings.
• Ability to interpret, describe and document clinical data.
• Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
• Computer skills and general computer literacy.
• Excellent English language skills (verbal and written).

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.
• Extensive support of work-life balance.
• Life insurance and pension plan.
• Private medical package with additional preventive healthcare services.
• Sports cards (Multisport).
• Possibilities of development within the role and company’s structure.
• Personalized learning approach.
• Supportive community and integration events.
• Modern office with creative rooms.

Inclusion & Diversity at GSK:

As an employer committed to Diversity and Inclusion, 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.

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Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses incurred on your behalf during the interview process.

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