- Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
- Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
- Demonstrated effectiveness in management of projects of increasing scope and complexity.
- Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
- Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
- High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
- Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
- Review reporting and analysis plans and provides critical input on the content and display of tables.
- Familiarity with approaches to expedite document preparation such as review tools and automation.
- Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
- Effectiveness in both oral and written communications.
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNombre del sítio: Bengaluru Luxor North Tower · Fecha de publicación: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, a ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERİş Yeri: Bengaluru Luxor North Tower · Yayın tarihi: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission docum ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNome do Local: Bengaluru Luxor North Tower · Data da Publicação: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and re ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNombre del sítio: Bengaluru Luxor North Tower · Fecha de publicación: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERStandort: Bengaluru Luxor North Tower · Datum: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulat ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNazwa biura: Bengaluru Luxor North Tower · Posted Date: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses t ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERStandort: Bengaluru Luxor North Tower · Datum: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERTên địa điểm: Bengaluru Luxor North Tower · Ngày đăng tuyển: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and respon ...
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Medical Writer
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Clario Bengaluru, Karnataka, IndiaAre you seeking a purposeful and rewarding Medical Writing career opportunity? · - Our Cardiac Safety, Respiratory & Precision Motion teams are growing in India, and with big ambitions and a clear vision for the future, now is the time to join Clario as a Medical Writer.- · - Wha ...
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GSK Bengaluru, India**Site Name**: Bengaluru Luxor North Tower · **Posted Date**: Feb · **Job Purpose**: · The Medical Writer is expected to work under guidance of a mentor or independently, facilitating delivery of the written assignments through proactive coordination of stakeholders to build con ...
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Medcafe solutions Bengaluru, India**MEDICAL WRITER - remote working (MPharm, PharmD, PhD, MBBS, MD)** · **About us**: Medcafe Solutions is a pharma/healthcare start-up with a mission to transform the medical affairs to be a key strategic partner. We are building a large team of medics with diverse and robust medi ...
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Novo Nordisk Bengaluru, IndiaMedical Writer · **Category**:Clinical Development**Location**:Bangalore, Karnataka, IN**Department - Clinical Reporting Unit**About the department** · - The Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical R ...
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MMS Bengaluru, IndiaPractices good internal and external customer service · - Responsible for scientific medical writing and producing high quality documents · - Understands ICH guidelines, as applicable to medical writing for clinical studies · - Creates medical writing training exercises; mentors ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNazwa biura: Bengaluru Luxor North Tower · Posted Date: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission do ...
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Practo Technologies Bengaluru, India**Job Role and Responsibilities**: · - To research and develop an online drug database. · - Review pharma contents as and when required by the organization. · - To maintain hygiene in the drug database through periodic monitoring and ensuring that the database is up to date and c ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERTên địa điểm: Bengaluru Luxor North Tower · Ngày đăng tuyển: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submissi ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNom du site: Bengaluru Luxor North Tower · Data de publication: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and res ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNom du site: Bengaluru Luxor North Tower · Data de publication: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submi ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNome della sede: Bengaluru Luxor North Tower · Data di apertura: Apr Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and re ...
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Principal Medical Writer
1 week ago
GSK Bengaluru, India OTHERNome della sede: Bengaluru Luxor North Tower · Data di apertura: Apr · Key Responsibilities (suggested no more than 10 bullet points) · Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD subm ...
Principal Medical Writer - Bengaluru, India - GSK
Description
Nome do Local: Bengaluru Luxor North TowerData da Publicação: Apr
Key Responsibilities (suggested no more than 10 bullet points)
Nossa meta é ser uma das empresas da área de saúde mais inovadoras, com o melhor desempenho e confiáveis do mundo. Acreditamos que todos nós trazemos algo de exclusivo para a GSK, e quando combinamos nosso conhecimento, experiências e estilos, o impacto é incrível. Venha participar de nossa aventura na GSK onde você será inspirado a fazer seu melhor trabalho para nossos pacientes e consumidores. Um lugar onde você pode ser você mesmo, sentir-se bem e continuar crescendo.
Notificação importante para empresas/agências de emprego
A GSK não aceita indicações de empresas e/ou agências de emprego para as vagas publicadas neste site. Todas as empresas/agências de emprego devem entrar em contato com o departamento de recursos humanos/aquisição geral e comercial da GSK para obter autorização prévia, por escrito, antes de indicar quaisquer candidatos para a GSK. A obtenção da autorização prévia, por escrito, é uma condição anterior a qualquer acordo (verbal ou por escrito) entre a empresa/agência de emprego e a GSK. Na ausência dessa autorização por escrito, será considerado que todas as ações foram executadas pela empresa/agência de emprego sem o consentimento ou o acordo contratual da GSK. Dessa forma, a GSK não será responsável por valores decorrentes dessas ações nem por valores decorrentes de indicações feitas por empresas/agências de emprego para as vagas publicadas neste site.