- Produce well-written, high-quality, timely Medical Writing documents (like Clinical Study Reports, Protocols and amendments, Investigator's Brochure [IB] and IB updates, etc)
- Review (including peer and QC review) Medical Writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed
- Proof-read and provide editorial support on documents produced by other departments in Quanticate or by clients, if requested
- Provide oversight on Medical Writing projects and/or cross-functional projects using project management tools and processes
- Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed
- Assist Principal Medical Writers and above with the management of department budget and financials
- Actively contribute to business development by keeping CV up-to-date, preparing and reviewing client proposals and other business development documentation, as well as presenting at client meetings and bid defense meetings
- Line manage assigned personnel taking an active role in their development and provide guidance and mentorship to less experienced Medical Writers
- Conduct literature reviews and provide input on the development of scientific communication and messaging
- Manage timelines and deliver documents within established deadlines
- Master's degree or higher in a life science or related field.
- Minimum 5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
- Strong knowledge of clinical research, regulatory requirements, and industry guidelines (ICH-GCP).
- Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific information effectively.
- Experience in writing clinical study documents, such as protocols, clinical study reports, and regulatory submission documents.
- Detail-oriented with excellent organizational and time management skills.
- Ability to work independently and collaboratively in a team environment.
- Competitive Salary (Open to discussion based on experience)
- Flexible working hours
- Holidays (Annual leave, sick leave, casual leave and bank holidays)
- Medical Insurance for self and immediate family
- Gratuity
- Accidental Coverage
- Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)
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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
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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 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 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 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
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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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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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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
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 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 · 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 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 ...
Senior Medical Writer - Bengaluru, India - Quanticate
Description
Quanticate is seeking a talented and experienced Senior Medical Writer to join our Medical Writing team in India. As a leading global clinical research organization, Quanticate works with pharmaceutical, biotechnology, and medical device companies to support their regulatory and scientific communication needs. The Senior Medical Writer will be responsible for developing high-quality clinical study documents, including protocols, clinical study reports, and regulatory submission documents. They will collaborate with cross-functional teams and ensure adherence to guidelines and timelines.
The Senior Medical Writer will have a deep understanding of clinical research and regulatory requirements. They will possess excellent writing, editing, and proofreading skills, with the ability to translate complex scientific data into clear, concise, and accurate documents. The ideal candidate is detail-oriented, highly organized, and able to work effectively in a fast-paced and deadline-driven environment.
Responsibilities:
Requirements
Benefits
Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at