- 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 OTHERNome do Local: Bengaluru Luxor North Tower · Data da Publicação: 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 ...
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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
2 days ago
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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Medical Writer
3 days ago
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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Medical Writer
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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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Medical Writer
1 week ago
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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Medical Writer
2 days ago
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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Medical Writer
1 week ago
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 · 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 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 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 ...
Principal Medical Writer - Bengaluru, India - GSK
Description
Nome della sede: Bengaluru Luxor North TowerData di apertura: Apr
Key Responsibilities (suggested no more than 10 bullet points)
Il nostro obiettivo è di essere una delle aziende sanitarie all'avanguardia in termini di innovazione, performance e affidabilità nel mondo. Crediamo che ognuno di noi contribuisca portando qualcosa di unico in GSK e quando uniamo le nostre conoscenze, esperienze e stili, il risultato è fantastico. Unisciti alla nostra avventura in GSK, dove troverai l'ispirazione per lavorare al meglio per i nostri pazienti e consumatori. Un luogo dove puoi essere te stesso, sentirti bene e continuare a crescere.
Avviso importante per le imprese/agenzie per l'occupazione
GSK non accetta referenze da parte di aziende e/o agenzie di collocamento in relazione alle offerte di lavoro pubblicate su questo sito. Tutte le aziende/agenzie di collocamento sono tenute a contattare l'ufficio commerciale e il reparto generale/risorse umane di GSK per ottenere un'autorizzazione scritta prima di segnalare eventuali candidati a GSK. L'ottenimento della previa autorizzazione scritta è una condizione sospensiva rispetto a qualsiasi accordo (verbale o scritto) tra l'azienda/agenzia di collocamento e GSK. In assenza di tale autorizzazione scritta ottenuta, qualsiasi azione intrapresa dall'azienda/agenzia di collocamento verrà considerata eseguita senza il consenso o l'accordo contrattuale di GSK. GSK non sarà quindi responsabile per eventuali commissioni derivanti da tali azioni o commissioni derivanti da eventuali segnalazioni da parte di aziende/agenzie di lavoro in relazione alle offerte di lavoro pubblicate su questo sito.