Principal Medical Writer
2 weeks ago
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 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
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 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 time勤務地: Bengaluru Luxor North Tower公開日: 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 time勤務地: Bengaluru Luxor North Tower公開日: 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 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 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...
