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).

Neden GSK?

Hastalıkların önüne geçmek için bilimi, teknolojiyi ve yeteneği bir araya getiriyoruz.

GSK, bilimi, teknolojiyi ve yeteneği birleştirerek hastalıkların önüne geçmeyi amaçlayan global bir biyofarma şirketidir. Çalışanlarının gelişimini destekleyen, başarılı ve büyüyen bir şirket olarak önümüzdeki beş yıl içinde 2,5 milyar insanın sağlığını olumlu yönde etkilemeyi hedefliyoruz. Uzmanlık ilaçları ve aşılarda sunduğumuz inovatif koruma ve tedavi yöntemleriyle hastalıkların önüne geçiyoruz. Sağlığı geniş ölçekte etkilemek için solunum, immünoloji ve inflamasyon; onkoloji; HIV ve enfeksiyon hastalıkları olmak üzere dört terapötik alana odaklanıyoruz.

Dünyanın her köşesinde ürettiğimiz ilaç ve aşılara güvenildiğini biliyor, bu yüzden çalışanlarımıza gelişebilecekleri ve etki yaratacak noktalara odaklanabilecekleri bir çalışma ortamı sağlıyoruz. Hastalar için tutkulu olma, etkimiz için özsorumlu olma ve her koşulda doğru olanı yapma kültürümüz; hastalar, paydaşlarımız ve çalışanlarımız için attığımız her adımın temelinde yer alıyor.

GSK'da Kapsayıcılık:

Kapsayıcılığa kendini adamış bir işveren olarak, işe alım süreci boyunca herhangi bir desteğe ihtiyacınız olursa bize ulaşmanızı öneririz. Lütfen ihtiyaçlarınızı görüşmek için IN.recruitment- adresinden İşe Alım Ekibimizle iletişime geçin.

İstihdam işletmelerine/Ajanslarına Önemli Duyuru

GSK, bu sitede yayınlanan boş pozisyonlar için istihdam işletmeleri veya işe alım danışmanlıklarından yönlendirmeleri kabul etmemektedir. Tüm istihdam işlemleri ve işe alım danışmanlıklarının, herhangi bir adayı GSK'ya yönlendirmeden önce yazılı ön izin almak için GSK'nın ticari birimleri ve Satınalma/İnsan Kaynakları departmanıyla iletişime geçmeleri gerekmektedir. Önceden yazılı izin alınması, istihdam işletmeleri/işe alım danışmanlıkları ile GSK arasındaki herhangi bir anlaşmanın (sözlü veya yazılı) ön koşuludur. Böyle bir yazılı izin alınmaması durumunda, istihdam işletmesi/danışmanlık tarafından gerçekleştirilen herhangi bir eylemin GSK'nin onayı veya sözleşmesi olmadan gerçekleştirildiği kabul edilir. Bu nedenle GSK, bu tür eylemlerden kaynaklanan herhangi bir ücretten veya istihdam işletmeleri/danışmanlıklar tarafından bu sitede yayınlanan boş pozisyonlar ile ilgili olarak yapılan herhangi bir yönlendirmeden kaynaklanan herhangi bir ücretten sorumlu tutulamaz.

GlaxoSmithKline, GSK veya grup şirketlerimizin isimlerinin, sahte iş ilanlarında veya adaylardan işe alım fırsatları ve mülakatlar için ödeme talep eden istenmeyen e-postalar yoluyla kullanıldığını fark etmiş bulunmaktayız. Lütfen bu tür ilanların ve e-postaların GlaxoSmithKline grubu ile hiçbir şekilde bağlantılı olmadığını unutmayın.

GlaxoSmithKline (veya GSK) grup şirketlerinden herhangi birinin dünya genelindeki herhangi bir lokasyonunda, işe alım süreci ile ilgili olarak hiçbir bireye veya kuruluşa – iade edileceği iddia edilse bile – kesinlikle ödeme yapmayınız.

Eğer ile bitmeyen bir e-posta adresinden gelen istenmeyen bir e-posta alırsanız veya böyle bir adrese ulaşmanızı isteyen iş ilanlarıyla karşılaşırsanız, lütfen bu iletileri dikkate almayınız ve ilan/mesajın gerçekliğini doğrulayabilmemiz adına adresi üzerinden bizimle iletişime geçiniz.