Key Responsibilities - - Independently lead preparation of complex clinical and post-market safety documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US Periodic Adverse Drug Experience Reports/Periodic Adverse Experience Reports (PADERs/PAERs), RMPs and responses to regulatory authority questions.
- Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
- Lead cross-functional teams in document preparation including but not limited to development of content strategy, coordination of content contributions, organization of review schedules, and project timelines.
- Work in a matrix team to ensure delivery of high-quality, fit-for-purpose documents that reflect accurate interpretation of associated safety, clinical, and statistical data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
- Understand the interdependencies of various contributing functions (e.g., safety, regulatory, clinical, epidemiology, statistics and programming).
- Anticipate and evaluate complex situations and problems, resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders.
- Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents.
- Use approaches to expedite document preparation, including authoring and reviewing tools, as well as other automation/technology platforms.
- Serve as a mentor for less experienced writers.
- Develop and deliver training on medical writing topics.
- Lead initiatives to improve medical writing processes.
- Contribute to vendor oversight as needed.
Basic Qualifications - - Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.
- In depth working knowledge of:
- Relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements.
- Core cross-functional clinical research roles and procedures, and how they relate to document strategy and operational preparation.
- Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time.
- Advanced understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write complex safety documents.
Other Qualifications - - Advanced safety writing skills with expertise in most safety document types.
- Highly collaborative, capable of leading cross functional team members, negotiating solutions, and advising them on document structure and content as needed.
- Skilled in navigating multicultural settings, ensuring effective collaboration with diverse customers and clients, such as health authorities and patients, while adeptly collaborating with remote teams.
- Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule.
- Advanced computer skills and general computer literacy.
- Excellent English language proficiency, both verbal and written
Why GSK
Uniting science, technology and talent to get ahead of disease together.
GSK is 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
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