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.

Dlaczego GSK?

Łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby.

GSK to globalna firma biofarmaceutyczna, której celem jest łączenie nauki, technologii i talentów, aby wspólnie wyprzedzać choroby. Jako odnosząca sukcesy, rozwijająca się firma, w której ludzie mogą realizować swój potencjał, dążymy do pozytywnego wpływu na zdrowie 2,5 miliarda ludzi do końca dekady.

Priorytetem są dla nas innowacyjne rozwiązania w obszarze szczepionek i leków specjalistycznych, które maksymalizują rosnące możliwości w zakresie zapobiegania chorobom i ich leczenia.

Skupiamy się na czterech obszarach terapeutycznych: układzie oddechowym, immunologii; onkologii; HIV; oraz chorobach zakaźnych – aby wpływać na zdrowie na dużą skalę.

Ludzie i pacjenci na całym świecie polegają na lekach i szczepionkach, które produkujemy, dlatego zobowiązujemy się do tworzenia środowiska, w którym nasi pracownicy mogą się rozwijać i koncentrować na tym, co najważniejsze. Nasza kultura bycia ambitnym dla pacjentów, odpowiedzialnym za wpływ i postępowania właściwie jest fundamentem, na którym wspólnie dostarczamy rezultaty dla pacjentów, akcjonariuszy i naszych pracowników.

Inkluzywność w GSK:

Jako pracodawca zaangażowany w kwestie inkluzywności, zachęcamy do kontaktu, jeśli potrzebujesz jakichkolwiek zmian w trakcie procesu rekrutacji.

Skontaktuj się z naszym zespołem ds. rekrutacji pod adresem IN.recruitment-, aby omówić swoje potrzeby.

Ważna informacja dla firm/agencji zatrudnienia

GSK nie przyjmuje poleceń od firm/agencji rekrutacyjnych lub pośrednictwa pracy w odniesieniu do wakatów zamieszczonych na tej stronie. Wszystkie firmy/agencje są zobowiązane do skontaktowania się z Działem Zakupów Usług Komercyjnych/Działem HR GSK w celu uzyskania uprzedniej pisemnej zgody przed skierowaniem jakichkolwiek kandydatów do GSK. Uzyskanie uprzedniej pisemnej zgody jest warunkiem wstępnym każdej umowy (ustnej lub pisemnej) między firmą/agencją a GSK. W przypadku braku takiego pisemnego upoważnienia wszelkie działania podejmowane przez firmę/agencję będą uznawane za wykonane bez zgody lub umowy kontraktowej GSK. GSK nie ponosi zatem odpowiedzialności za żadne opłaty wynikające z takich działań lub opłaty wynikające z jakichkolwiek poleceń firm/agencji w odniesieniu do wakatów zamieszczonych na tej stronie.

Dotarła do nas informacja, że nazwy GlaxoSmithKline lub GSK lub spółek naszej grupy są wykorzystywane w związku z fałszywymi ogłoszeniami o pracę lub za pośrednictwem niezamawianych wiadomości e-mail, w których kandydaci są proszeni o dokonanie pewnych płatności za możliwości rekrutacji i rozmowy kwalifikacyjne. Należy pamiętać, że takie reklamy i wiadomości e-mail nie są w żaden sposób powiązane z grupą GlaxoSmithKline (lub GSK).

GlaxoSmithKline (lub GSK) nie pobiera żadnych opłat za proces rekrutacji. Prosimy nie dokonywać płatności na rzecz żadnych osób/podmiotów w związku z rekrutacją w żadnej spółce grupy GlaxoSmithKline (lub GSK) w żadnej lokalizacji na świecie. Nawet jeśli twierdzą, że pieniądze podlegają zwrotowi.

Jeśli natkniesz się na niechciane wiadomości e-mail z adresów, które nie kończą się na lub na ogłoszenia o pracę, w których napisano, że należy kontaktować się z adresem e-mail, który nie kończy się na "", powinieneś je zignorować i poinformować nas, wysyłając wiadomość e-mail na adres , abyśmy mogli potwierdzić, czy oferta pracy jest prawdziwa.