- 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
3 weeks 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
3 weeks 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
3 weeks 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
3 weeks 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
3 weeks 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
3 weeks 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
3 weeks 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
3 weeks 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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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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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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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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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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Principal Medical Writer
3 weeks 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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Principal Medical Writer
3 weeks 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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Bregma Science LLP Bengaluru, IndiaBregma Science has been providing research, publication, and training services since 2016 in the global market. Bregma offers end-to-end consultancy to entrepreneurs, research institutes, and established businesses in pharma and healthcare sectors. · Job Responsibilities: · 1. Wr ...
Principal Medical Writer - Bengaluru, India - GSK
Description
Standort: Bengaluru Luxor North TowerDatum: Apr
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.