Principal Medical Writer
2 weeks ago
Tanggal 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 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.
Tujuan kami adalah menjadi salah satu perusahaan perawatan kesehatan yang paling inovatif, berkinerja terbaik, dan tepercaya di dunia. Kami meyakini bahwa kami semua membawa sesuatu yang unik ke GSK, dan dengan memadukan pengetahuan, pengalaman, dan gaya kami, dampaknya akan luar biasa. Bergabunglah dengan petualangan kami di GSK, di mana Anda akan terinspirasi untuk melakukan yang terbaik bagi pasien dan konsumen kita. Tempat di mana Anda menjadi diri sendiri, merasa baik, dan terus berkembang.
Pemberitahuan penting kepada Bisnis/Agen ketenagakerjaan
GSK tidak menerima rujukan dari bisnis ketenagakerjaan dan/atau agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini. Semua bisnis/agen ketenagakerjaan harus menghubungi departemen pengadaan komersial dan umum/sumber daya manusia GSK untuk memperoleh otorisasi tertulis sebelum merujuk kandidat ke GSK. Mendapatkan otorisasi tertulis sebelumnya merupakan prasyarat sebelum perjanjian apa pun (lisan atau tertulis) antara bisnis/agen ketenagakerjaan dan GSK. Jika otorisasi tertulis tersebut tidak diperoleh, maka tindakan apa pun yang dilakukan oleh bisnis/agen ketenagakerjaan akan dianggap telah dilakukan tanpa persetujuan atau perjanjian kontrak dengan GSK. Dengan demikian GSK tidak bertanggung jawab atas biaya apa pun yang ditimbulkan oleh tindakan tersebut atau biaya apa pun yang ditimbulkan oleh rujukan apa pun oleh bisnis/agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini.
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
