Associate Director Medical Writing

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 Associate Director, Safety Writing, is responsible for leading the safety writing team and ensuring accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans (RMP). They will provide essential oversight and input into all aspects of aggregate reports and RMP preparation. They will participate in process improvements and foster an environment for idea generation.

Key Responsibilities (suggested no more than 10 bullet points)

• Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio. Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams. Set annual objectives to meet writers' capabilities, development potential and business needs (People Management/Development).

• Ensure medical writers are trained in relevant procedures, policies and standards to be applied for safety writing activities. Lead development of training materials for safety documents, and provide mentoring, coaching and/or training to individuals or teams. Promote best writing practices and build capability (ICH, GCP/GVP standards, process development, application and alignment).

• Evaluate resources required for safety writing activities to ensure alignment with the organizations' strategic and operational objectives (Setting priorities and resource management). Provide project updates to leadership and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements.

• Interface with the cross-functional safety teams, and third parties, as required, to ensure appropriate input and alignment with stakeholders for the resourcing and generation of safety reports in scope (On-time delivery with quality).

• Drive and implement key organizational process improvement initiatives. Proactively generate ideas for improvement and promote an empowering environment for others to generate ideas (e.g., for accelerated, simplified processes); champion improvements in technology and ways of working.

• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall project performance.

• In collaboration with the MW leadership team and the Safety leadership team, measure and monitor efficiency and quality of the team's output, collect and evaluate metrics to identify the need for improvement in processes, staff educational activities, etc.

Education Requirements (minimum expected)

Minimum qualification required would be a master's degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage.

Job Related Experience (minimum requirements)

6-8 years' experience in safety writing, including leading the development of safety reports in a post-market setting within the pharmaceutical/ Contract Research Organization industry.

Other Job-Related Skills

• Demonstrate experience in working in matrix/ multicultural settings and diverse environments particularly with respect to dynamics of working with hybrid teams.

• Highly pragmatic with strong negotiation skills (to propose creative solutions to new challenges). Demonstrate leadership skills and the ability to identify and evaluate viable options to make decisions in a timely and effective manner.

• Ability to plan work to meet deadlines and effectively handle multiple priorities.

• Ability to understand medical-scientific data from a broad range of therapeutic areas.

• Strategic skills with strong planning and organizational skills. Exhibits the ability to analyze complex issues using data, logic, and judgment to identify problems, determine root cause, and recommend solutions to resolve and prevent issues.

• Outstanding knowledge of written and spoken English.

• Ability to mentor and understand selection of essential information, logical flow, clarity, accuracy appropriate for target audiences (e.g., regulatory authorities).

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 Associate Director, Safety Writing, is responsible for leading the safety writing team and ensuring accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans (RMP). They will provide essential oversight and input into all aspects of aggregate reports and RMP preparation. They will participate in process improvements and foster an environment for idea generation.

Key Responsibilities (suggested no more than 10 bullet points)

• Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio. Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams. Set annual objectives to meet writers' capabilities, development potential and business needs (People Management/Development).

• Ensure medical writers are trained in relevant procedures, policies and standards to be applied for safety writing activities. Lead development of training materials for safety documents, and provide mentoring, coaching and/or training to individuals or teams. Promote best writing practices and build capability (ICH, GCP/GVP standards, process development, application and alignment).

• Evaluate resources required for safety writing activities to ensure alignment with the organizations' strategic and operational objectives (Setting priorities and resource management). Provide project updates to leadership and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements.

• Interface with the cross-functional safety teams, and third parties, as required, to ensure appropriate input and alignment with stakeholders for the resourcing and generation of safety reports in scope (On-time delivery with quality).

• Drive and implement key organizational process improvement initiatives. Proactively generate ideas for improvement and promote an empowering environment for others to generate ideas (e.g., for accelerated, simplified processes); champion improvements in technology and ways of working.

• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall project performance.

• In collaboration with the MW leadership team and the Safety leadership team, measure and monitor efficiency and quality of the team's output, collect and evaluate metrics to identify the need for improvement in processes, staff educational activities, etc.

Education Requirements (minimum expected)

Minimum qualification required would be a master's degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage.

Job Related Experience (minimum requirements)

6-8 years' experience in safety writing, including leading the development of safety reports in a post-market setting within the pharmaceutical/ Contract Research Organization industry.

Other Job-Related Skills

• Demonstrate experience in working in matrix/ multicultural settings and diverse environments particularly with respect to dynamics of working with hybrid teams.

• Highly pragmatic with strong negotiation skills (to propose creative solutions to new challenges). Demonstrate leadership skills and the ability to identify and evaluate viable options to make decisions in a timely and effective manner.

• Ability to plan work to meet deadlines and effectively handle multiple priorities.

• Ability to understand medical-scientific data from a broad range of therapeutic areas.

• Strategic skills with strong planning and organizational skills. Exhibits the ability to analyze complex issues using data, logic, and judgment to identify problems, determine root cause, and recommend solutions to resolve and prevent issues.

• Outstanding knowledge of written and spoken English.

• Ability to mentor and understand selection of essential information, logical flow, clarity, accuracy appropriate for target audiences (e.g., regulatory authorities).

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.