Senior Medical Writer
3 months ago
Qualification(s)
- Bachelor’s Degree/Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred.
Experience(s)
- Publication experience in scientific journals preferable
- Minimum 3 years of experience in Medical Device Regulatory documentation
- Familiarity with the Life Sciences Industry, preferably Regulatory Services
- Hands on experience on CEP/CER/PMSR/PSUR process
- Experience in creating high quality deliverables for customers
- Experience in handling projects and engaging with multiple clients independently
- Experience of working on projects involving all devices classes from various Therapeutic Areas
Technical Skills
- Knowledge of clinical evaluation and related documents and regulatory requirements
- Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature
- Proficiency with Microsoft Office (Word, Excel, and Outlook)
- Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage.
- Effective reviewing skills for review of work done by trainees/junior writers.
Soft Skills
- Strong verbal and written communications skills
- Ability to work as part of a team.
- A constant zeal towards learning and skill development
- Potential to multitask and work within timelines.
- Ability to understand and deliver on customer requirements.
- Mentoring skills to act as trainer/mentor for junior members of the team
Competencies
- Basic English grammar, punctuation, and sentence construction
- Logical comprehension
- Knowledge of medical terminology
- Excellent Communication (Writing and Verbal)
- Quality focused mindset
- Good time management
- Good stakeholder management
Personal Traits
- Positive Attitude, Initiative and Commitment, Detail Oriented, Team player, Focused and sincere, Ownership and accountability of work.
Roles and Responsibilities
- Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas
- Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
- Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation.
- Assist the Team Lead/Manager in the development of schedules to ensure timely delivery.
- Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
- Train and mentor junior members of the team on technical/process related aspects
- Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities
- Perform literature searches on various databases.
- Screening, appraisal per pre-defined criteria, and summarization of articles
- Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use
- Summarize quantitative data from post-marketing surveillance.
- Conduct editing, proofreading, document formatting, and other document completion/approval activities.
-
Senior Medical Writer/Medical Writer
4 months ago
Bengaluru, India VCLS Full timeSenior Medical Writer/Medical WriterVCLS is seeking a highly skilled Senior Medical Writer/Medical Writer to join our team. In this role, you will be responsible for authoring high-quality medical documents for various client projects, including drugs, biologics, and Advanced Therapy Medicinal Products (Cell-, Gene- and Tissue therapies). Your primary goal...
-
Senior Medical Writer
4 months ago
Bengaluru, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Senior Medical Writer The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple...
-
Senior Medical Writer
4 days ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout the RoleWe are seeking an experienced Senior Medical Writer to join our team at Lifelancer. As a Senior Medical Writer, you will be responsible for developing and finalizing clinical and scientific documents for regulatory submissions.
-
Regulatory Writer
1 month ago
Greater Bengaluru Area, India Celegence Full timeSenior Medical Writer Job OpportunityWe are seeking a skilled and experienced Regulatory Writer to join our team at Celegence. As a Senior Medical Writer, you will be responsible for developing high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4 and MDR for Medical Devices.The ideal candidate will have a degree in Life Sciences, minimum 3...
-
Senior Medical Writer
3 months ago
Greater Bengaluru Area, India Celegence Full timeQualification(s) Bachelor’s Degree/Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred. Experience(s) Publication experience in scientific journals preferable Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Hands on...
-
Medical Writer
7 months ago
Bengaluru, Karnataka, India ChanRe Healthcare & Research Full timeLifescience/Medical graduate to work as a Medical writer Demonstrated skills in Literature search, Content development Hands on experience with MS office tools, proof reading, Medical thesis writing, Systematic review writing, Meta analysis writing **Salary**: ₹15,000.00 - ₹25,000.00 per month Schedule: - Day shift
-
Medical Writer 2
7 months ago
Bengaluru, Karnataka, India Novasyte Full timeJob Overview Acts as Lead Medical Writer on more advanced writing projects (e.g. complex clinical study reports, protocols, more challenging indications, or customers). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. May provide feedback to peers when...
-
Manuscript Writer/Medical Writer
14 hours ago
Bengaluru, India MS CLINICAL RESEARCH Full timeAbout Us:MS Clinical Research Pvt Ltd (MSCR) is a leading clinical research organization dedicated to advancing healthcare through innovative research and scientific excellence. We collaborate with global pharmaceutical and biotechnology companies to deliver impactful solutions. As part of our growing operations, we are seeking a skilled Manuscript...
-
Medical Writer
7 months ago
Bengaluru, India Novo Nordisk Full timeMedical 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 Reporting community in a short span of 6-7 years, since its inception in 2011. The...
-
Principal Medical Writer, Medical Writing Services
4 months ago
Bengaluru, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. The Principal Medical Writer, will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on...
-
Manuscript Writer/Medical Writer
2 days ago
Bengaluru, India MS CLINICAL RESEARCH Full timeAbout Us:MS Clinical Research Pvt Ltd (MSCR) is a leading clinical research organization dedicated to advancing healthcare through innovative research and scientific excellence. We collaborate with global pharmaceutical and biotechnology companies to deliver impactful solutions. As part of our growing operations, we are seeking a skilled Manuscript...
-
Manuscript Writer/Medical Writer
2 days ago
Bengaluru, India MS CLINICAL RESEARCH Full timeAbout Us:MS Clinical Research Pvt Ltd (MSCR) is a leading clinical research organization dedicated to advancing healthcare through innovative research and scientific excellence. We collaborate with global pharmaceutical and biotechnology companies to deliver impactful solutions. As part of our growing operations, we are seeking a skilled Manuscript...
-
Manuscript Writer/Medical Writer
1 day ago
Bengaluru, India MS CLINICAL RESEARCH Full timeAbout Us: MS Clinical Research Pvt Ltd (MSCR) is a leading clinical research organization dedicated to advancing healthcare through innovative research and scientific excellence. We collaborate with global pharmaceutical and biotechnology companies to deliver impactful solutions. As part of our growing operations, we are seeking a skilled Manuscript...
-
Medical Writer
7 months ago
Bengaluru, Karnataka, India Clario Full timeAre 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.- - What we offer:- Competitive compensation + shift allowances - Attractive benefits...
-
Regulatory Medical Writer Lead
3 weeks ago
Bengaluru, Karnataka, India Indegene Full timeAbout the CompanyIndegene is a technology-led healthcare solutions provider driven by its purpose to enable healthcare organizations be future ready. With accelerated, global growth opportunities for talent that's bold, industrious, and nimble, Indegene offers a unique career experience that celebrates entrepreneurship, passion, innovation, collaboration,...
-
Medical Writer
7 months ago
Bengaluru, India Clario Full timeAre 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. These positions are subject to Indian, European and US working hour shift patterns, and...
-
Medical Writer
3 weeks ago
Bengaluru, Karnataka, India GSK Full time**Site Name**: Bengaluru Luxor North Tower **Posted Date**: Dec 13 2024 **Years of Experience: 3 - 5 years** **Skill Set / Exposure: Clinical and Regulatory document writing, Protocol, CSR and Modules (m2 & m5).** **Work Location: Bengaluru** **Job Purpose**: - The Medical Writer is expected to work under guidance of a mentor or independently,...
-
Senior Medical Writer
3 months ago
Bangalore Metropolitan Area, India Celegence Full timeQualification(s)Bachelor’s Degree/Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred. Experience(s)Publication experience in scientific journals preferable Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Hands on experience...
-
Medical Writer I
6 months ago
Bengaluru, Karnataka, India Icon plc Full timeAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Medical Writer Lead
2 weeks ago
Bengaluru, Karnataka, India Indegene Full timeAbout the RoleWe are seeking an experienced Medical Writer Lead to join our medical writing team. This role requires a strong background in scientific communication, with a focus on creating high-quality content for various audiences.The ideal candidate will have a PhD or PharmD degree in a related field and at least 4-10 years of experience in medical...