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
Job Purpose :
The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analysed 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 has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has the ability to plan and prioritize without supervision.
Key Responsibilities:
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
Proven track record in writing a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, Informed consent forms (ICF), clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents (BD), and responses to regulatory authority questions.
Work 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.
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
Demonstrated effectiveness in management of projects of increasing scope and complexity.
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
Review reporting and analysis plans and provides critical input on the content and display of tables.
Familiarity with approaches to expedite document preparation such as review tools and automation.
Can mentor junior writers
Demonstrated ability and willingness to adjust behaviours and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
Effectiveness in both oral and written communications. And invite you to tell us
Knowledge/Education Required :
PhD or equivalent expertise (e.g., a master’s degree with relevant experience)
Life sciences PhD is the minimum post graduate entry qualification required for this grade. The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences. The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience.
A PhD is the global industry standard for medical writers, and a significant number of the current Medical Writing department has PhDs. This reflects the experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience.
Previous Experience Required :
Minimum Level of Job-Related Experience Required Why is this level of experience required
Preferably at least 5 years clinical regulatory writing experience in the pharmaceutical industry
This level of experience is required to provide expertise for assigned activities and to work independently on projects.
List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
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 Harmonisation (ICH)/Good Clinical Practice (GCP).
Possesses necessary computer skills and general computer literacy.
Excellent English language skills (verbal and written)
Knowledge & Application :
Briefly describe HOW the level of knowledge required for this role is applied / used within the role. What does this job do as a result of the knowledge it requires
The level of knowledge required will be applied to work on assignments independently, coordinating delivery of the written assignments through proactive interaction with stakeholders to build content. The writer drives quality standards and process improvement in the global organization. The Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.
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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