Principal Medical Writer, Safety

GSK

6d•Hybrid

About The Position

The Principal Medical Writer is a senior subject-matter expert who independently drives the creation of high-stakes safety documents—such as aggregate reports and Risk Management Plans—by combining deep regulatory knowledge with sharp interpretation of safety data. This role leads end-to-end production of complex deliverables, navigates challenging data analyses and critical safety issues, and champions continuous improvement by promoting best practices and adopting new tools and technologies.

Requirements

Bachelor's degree or equivalent in a scientific discipline.
5 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.
Experience authoring relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements and 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

Nice To Haves

Advanced safety writing skills with expertise in most safety document types.
Experience in a highly collaborative environment, 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.

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.