Principal Medical Writer
2 weeks ago
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 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.
Naszym celem jest być jedną z najbardziej innowacyjnych, najlepiej działających i zaufanych firm z branży opieki zdrowotnej na świecie. Wierzymy, że wszyscy wnosimy coś wyjątkowego do GSK i kiedy łączymy naszą wiedzę, doświadczenia i styl, wpływ, jaki mamy na świat jest niesamowity. Dołącz do naszej przygody w GSK, gdzie zainspirujemy Cię do wykonywania najlepszej pracy dla naszych pacjentów i klientów. Miejsce, w którym możesz być sobą, czuć się dobrze i się rozwijać.
Ważna informacja dla biur/agencji pośrednictwa pracy
GSK nie akceptuje poleceń pracowników od biur i/lub agencji pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie. Wszystkie biura/agencje pośrednictwa pracy są zobowiązane do skontaktowania się z działem handlowym i ogólnym/kadr GSK w celu uzyskania wcześniejszej pisemnej zgody przed poleceniem kandydatów firmie GSK. Uzyskanie uprzedniej pisemnej zgody jest nadrzędne w stosunku do jakiejkolwiek umowy (ustnej lub pisemnej) między biurem/agencją pośrednictwa pracy a GSK. W przypadku braku takowego pisemnego upoważnienia wszelkie działania podejmowane przez biuro/agencję pośrednictwa pracy będą uważane za wykonane bez zgody lub umownego porozumienia ze strony GSK. GSK nie ponosi zatem odpowiedzialności za jakiekolwiek opłaty wynikające z takich działań lub wynikające z polecenia danej osoby przez biura/agencje pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie.
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Principal Medical Writer
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Principal Medical Writer
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Bengaluru, Karnataka, India GSK Full timeNom du site: Bengaluru Luxor North TowerData 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 responses to regulatory authority questions.Work in a matrix team to ensure delivery...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeSite Name: Bengaluru Luxor North TowerPosted 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 documents, investigator brochures, briefing documents, and responses to regulatory authority...
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Principal Medical Writer
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Bengaluru, Karnataka, India GSK Full timeNazwa biura: Bengaluru Luxor North TowerPosted 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 to regulatory authority questions.Work in a matrix team to ensure delivery of high...
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Principal Medical Writer
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeSite Name: Bengaluru Luxor North TowerPosted 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 to regulatory authority questions.Work in a matrix team to ensure delivery of high...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNombre del sítio: Bengaluru Luxor North TowerFecha 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 submission documents, investigator brochures, briefing documents, and responses to...
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Principal Medical Writer
2 weeks ago
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Principal Medical Writer
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Principal Medical Writer
2 weeks ago
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNome do Local: Bengaluru Luxor North TowerData 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 responses to regulatory authority questions.Work in a matrix team to ensure...
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Principal Medical Writer
2 weeks ago
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