Senior Medical Writer

Senior Medical Writer

The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The senior medical writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.

Key Responsibilities include, but are not limited to:

• Completes assignments independently or for more complex documents, under guidance of a mentor

• Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.

• Ensures high integrity of data interpretation, following negotiation with document team.

• Ensures the consistency and quality level of all documents that are issued.

• Actively participates in all planning, coordination and review meetings.

• Ability to work on 2-3 assignments simultaneously.

• Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.

• Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).

• Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.

Requirements:

• PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience)

• Up to 5 years clinical regulatory writing experience in the pharmaceutical industry

• A good understanding of basic drug development

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

• Understanding of how to interpret, describe and document clinical data.

• Working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).

• Strong IT skills

• 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 (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

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.

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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 – t