Principal 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

Job Purpose

The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents (e.g., aggregate reports and Risk Management Plans [RMPs]) and interpretation of safety data. They must demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology.

Key Responsibilities (suggested no more than 10 bullet points)

• 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.

Education Requirements (minimum expected)

Master's degree or equivalent in a scientific discipline. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital-based environment, would be an advantage.

Job Related Experience (minimum requirements)

• 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 Job-Related Skills

• 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.

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 Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents (e.g., aggregate reports and Risk Management Plans [RMPs]) and interpretation of safety data. They must demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology.

Key Responsibilities (suggested no more than 10 bullet points)

• 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.

Education Requirements (minimum expected)

Master's degree or equivalent in a scientific discipline. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital-based environment, would be an advantage.

Job Related Experience (minimum requirements)

• 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 Job-Related Skills

• 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 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- to discuss your needs.

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