Senior Medical Writer/Medical Writer

4 months ago


Bengaluru, India VCLS Full time

Senior Medical Writer/Medical Writer

VCLS 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 will be to deliver accurate and timely documents that meet regulatory standards and guidelines.

Responsibilities:

  • Act as the lead medical writer on client programs, ensuring the highest quality of deliverables.
  • Review draft and final documents prepared by VCLS consultants or clients, ensuring accuracy, consistency, and adherence to regulatory standards.
  • Draft and/or review clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, and clinical overviews.
  • Contribute to the writing of other regulatory documents, such as Orphan Drug Designation applications and Pediatric Investigation Plans.
  • Ensure that all documents comply with VCLS or client SOPs and style requirements.
  • Provide input into project scope and cost estimates.
  • Stay updated on relevant regulations and guidelines in medical writing.
  • Collaborate closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals.
  • Participate in client meetings and support business development activities as needed.

Requirements

  • Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical or biotech industry.
  • Bachelor's degree or higher in a scientific discipline.
  • Regulatory expertise
  • CRO experience is preferable
  • Strong understanding of ICH guidelines and regulatory requirements.
  • Experience with authoring clinical and regulatory documents, including study protocols, investigator brochures, and clinical study reports.
  • Excellent written and verbal communication skills.
  • Attention to detail and ability to prioritize tasks to meet deadlines.
  • Proficient in MS Office (Word, Excel, PowerPoint).
  • Ability to work independently and collaboratively within a team.
  • Knowledge of reference management and publication planning tools is a plus.

  • Senior Medical Writer

    4 months ago


    Bengaluru, India Parexel Full time

    When 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...

  • Medical Writer

    6 months ago


    Bengaluru, Karnataka, India ChanRe Healthcare & Research Full time

    Lifescience/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

    7 months ago


    Bengaluru, India Novo Nordisk Full time

    Medical 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...


  • Bengaluru, India Parexel Full time

    When 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...

  • Medical Writer

    7 months ago


    Bengaluru, Karnataka, India Clario Full time

    Are 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...

  • Medical Writer

    1 week 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,...

  • Medical Writer 2

    6 months ago


    Bengaluru, Karnataka, India Novasyte Full time

    Job 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...

  • Medical Writer

    7 months ago


    Bengaluru, India Clario Full time

    Are 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 Lead

    3 days ago


    Bengaluru, Karnataka, India Indegene Full time

    About 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...

  • Regulatory Writer

    3 weeks ago


    Greater Bengaluru Area, India Celegence Full time

    Senior 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...


  • Bengaluru, Karnataka, India Indegene Full time

    About 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 I

    6 months ago


    Bengaluru, Karnataka, India Icon plc Full time

    At 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,...

  • Junior Medical Writer

    6 months ago


    Bengaluru, Karnataka, India Healthminds Consulting Full time

    **Position: Junior Medical Writer**: **Education qualification**: Masters in Life Science/Dental/Pharma and has knowledge of publications **Experience**: 1 year minimum in content development highly desired **Skills**: - Ability to summarize content from published literature in a concise and meaningful manner, relevant to objectives provided by client. -...

  • Medical Writer

    4 months ago


    Bengaluru, India Recruise India Consulting Pvt Ltd Full time

    Gaint Global Pharma Company The RoleKey Responsibilities:Content Development: Write, edit, and proofread a variety of medical and scientific documents, including clinical study reports, regulatory submissions, journal articles, abstracts, posters, white papers, and more.Research: Conduct comprehensive literature reviews and gather relevant information from...


  • Bengaluru, Karnataka, India Veranex, Inc. Full time

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

  • Medical Writer

    1 month ago


    Greater Bengaluru Area, India Celegence Full time

    ABOUT THE COMPANY:Celegence LLC is a privately owned business based in Chicago, IL, USA, with offices in the UK, EU, and India. We provide customers consulting services and solutions to support their regulatory affairs operations and strategy. Our fully trained resources support companies in their day-to-day operations by ensuring global regulatory...

  • Medical Safety Writer

    6 months ago


    Bengaluru, India Alcon Full time

    Summary of Position: - Alcon is looking to hire Medical Safety Writer to join our Medical Safety Writing team at Bengaluru in India. This role will Support Global Medical Safety in preparation of regulatory safety documentation and ensure the safety documents comply with applicable standards and regulations across region_ Key Responsibilities: - Act as...

  • Medical Writer

    4 months ago


    Bengaluru, India Snaphunt Full time

    The OfferFlexible working optionsFantastic work cultureOpportunity to make a positive impactThe JobKey Responsibilities:Content Development: Write, edit, and proofread a variety of medical and scientific documents, including clinical study reports, regulatory submissions, journal articles, abstracts, posters, white papers, and more.Research: Conduct...

  • Medical Content Writer

    6 months ago


    Jayanagar, Bengaluru, Karnataka, India Mpower HR Full time

    Job Description: Medical Content WriterLocation: Jayanagar 3rd Block, Bangalore, IndiaExperience: 3 to 6 YearsBudget: 4 to 6 Lakh INR per annum About Us: We are a leading healthcare organization dedicated to providing high-quality medical content to healthcare professionals and patients alike. Our mission is to make medical knowledge accessible and...

  • Safety Medical Writer

    6 months ago


    Bengaluru, Karnataka, India Merck KGaA Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...