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. 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 Preferred candidate profile 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. Perks and benefits 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)

Role and Responsibilities

• 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. 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 Preferred candidate profile 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. Perks and benefits 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)