Senior Medical Writer

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D


Position Summary
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 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 Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Responsibilities

• Actively participates in document planning and review meetings.

• Demonstrates understanding of how to interpret and describe clinical data

• Raises and discusses concerns/ issues in an open and timely manner within the global Medical Writing Team

• Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives.

• Actively participates in document planning and review meetings.

• Raises and discusses concerns/ issues in an open and timely manner within the global team at GSK

• Establishes network of communication and continuously builds these relationships with stakeholders to facilitate efficient execution of assignment.

• Has ability to interpret, describe and document clinical data and discuss with team.

• Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives

Basic Qualification

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

• Possesses a good understanding of basic drug development

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

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

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

• Possesses necessary computer skills and general computer literacy.

• Excellent English language skills (verbal and written)

What we offer in the role
You will join a team that values respectful collaboration, continuous learning and accountability. You will gain exposure to global teams and complex clinical programs. You will have clear opportunities to broaden your technical skills and take on increasing responsibility.

How to apply
We welcome your application. Please include a CV and a short cover note describing one example of a clinical document you contributed to and the impact you had. If you need adjustments during the recruitment process, please contact the Recruitment Team at IN.recruitment-adjustments@gsk.com.

The annual base salary in Poland for new hires in this position ranges from PLN 166,500 to PLN 277,500 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.

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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