Principal Medical Writer
2 weeks ago
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, 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.
Unser Ziel ist es, eines der innovativsten, leistungsfähigsten und vertrauenswürdigsten Gesundheitsunternehmen der Welt zu werden. Wir sind davon überzeugt, dass jeder von uns einen einzigartigen Beitrag zu GSK leistet. Wenn wir unser Wissen, unsere Erfahrungen und besonderen Talente vereinen, werden wir ein unglaubliches Ergebnis erzielen. Kommen Sie zu GSK und finden Sie einen inspirierenden Arbeitsplatz, an dem Sie Ihr Bestes für unsere Patienten und Verbraucher geben. Ein Ort, an dem Sie ganz Sie selbst sein, sich wohlfühlen und weiterentwickeln können.
Wichtiger Hinweis für Arbeitsvermittlungsunternehmen/‐agenturen
GSK akzeptiert keine Empfehlungen von Arbeitsvermittlungsunternehmen und/oder Arbeitsvermittlungsagenturen für die auf dieser Website ausgeschriebenen freien Stellen. Alle Arbeitsvermittlungsunternehmen/‐agenturen müssen sich an die Abteilung für gewerbliche und allgemeine Beschaffung/Personalabteilung von GSK wenden, um die schriftliche Einwilligung einzuholen, bevor sie GSK Bewerber empfehlen. Der Erhalt einer schriftlichen Einwilligung ist Voraussetzung für jegliche Vereinbarung (sowohl mündlich als auch schriftlich) zwischen dem Arbeitsvermittlungsunternehmen/der Arbeitsvermittlungsagentur und GSK. Falls diese Genehmigung nicht erteilt wurde, wird davon ausgegangen, dass sämtliche Handlungen des Arbeitsvermittlungsunternehmens/der Arbeitsvermittlungsagentur ohne die Zustimmung von GSK oder ohne eine vertragliche Vereinbarung mit GSK unternommen wurden. Aus diesem Grund haftet GSK nicht für irgendwelche Gebühren, die aus solchen Handlungen oder aus Empfehlungen von Arbeitsvermittlungsunternehmen/‐agenturen für die auf dieser Website ausgeschriebenen freien Stellen entstehen.
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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 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
Bengaluru, Karnataka, India GSK Full timeLocație: Bengaluru Luxor North TowerData postării: 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 timeNazwa biura: 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...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeLocație: Bengaluru Luxor North TowerData postării: 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...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeMunkavégzés helye: Bengaluru Luxor North TowerKihirdetett időpont: 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
Bengaluru, Karnataka, India GSK Full timePobočka: Bengaluru Luxor North TowerDatum zveřejnění: 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...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNom du site: Bengaluru Luxor North TowerDate 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 submission documents, investigator brochures, briefing documents, and responses to regulatory...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeİş Yeri: Bengaluru Luxor North TowerYayın tarihi: 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 timeNama Site: Bengaluru Luxor North TowerTanggal Posting: 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 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
2 weeks ago
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
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNome della sede: Bengaluru Luxor North TowerData 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 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 time근무지: Bengaluru Luxor North Tower포스팅 날짜: 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...
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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
Bengaluru, Karnataka, India GSK Full time工作地點名稱: Bengaluru Luxor North Tower刊登日期: 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 timeTên địa điểm: Bengaluru Luxor North TowerNgày 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 submission documents, investigator brochures, briefing documents, and responses to...
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Principal Medical Writer
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNama Site: Bengaluru Luxor North TowerTanggal Posting: 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...
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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...
