Principal Medical Writer

4 weeks ago

Bengaluru, India ScaleneWorks Full time

The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data.
He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents.
He/she has the ability to plan and prioritize without supervision.
This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.
Key Responsibilities:
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 Global pharma company 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.
Education Requirements (minimum expected):
PhD or relevant working experience within the life sciences space.
Job Related Experience (minimum requirements):
PhD or relevant working experience within the life sciences space.
Clinical regulatory writing experience in the pharmaceutical industry
Demonstration of leadership.
Experience in multicultural settings (to reflect our external customers/clients (health authorities/patients) and diverse environments with respect to dynamics of human interaction (including working with remote teams)
Ability to interpret, describe and document clinical data.
Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
Computer skills and general computer literacy.
Excellent English language skills (verbal and written)

  • Principal Medical Writer

    4 days ago

    Bengaluru, Karnataka, India GSK Full time

    **Site Name**: Warsaw Rzymowskiego 53, Bengaluru Luxor North Tower, Mississauga Milverton Drive **Posted Date**: Apr 10 2025 **_ Principal Medical Writer_** Specifically for this position: - 7+ years of advanced regulatory medical writing experience (protocol, CSRs, briefing books, summary modules), prior experience in oncology and understanding of...

  • Principal Medical Writer

    2 weeks ago

    Bengaluru, India Syneos Health Commercial Solutions Full time

    **Overview** **Can you reach people with just a few words?** You express all of your ideas effortlessly, and have the skills to distill other people's ideas into their best possible form. Your messaging is not only clear and concise, but your medical expertise allows you to convey high-level scientific knowledge in meaningful and comprehensible...

  • Principal Medical Writer

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Site Name: Bengaluru Luxor North Tower, Mississauga Milverton DrivePosted Date: Oct Job Title: Principal Medical WriterBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...

  • Principal Medical Writer

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Site Name: Bengaluru Luxor North Tower, Mississauga Milverton DrivePosted Date: Oct Job Title: Principal Medical Writer Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...

  • Principal Medical Writer

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Nazwa biura: Bengaluru Luxor North Tower, Mississauga Milverton DrivePosted Date: Oct Job Title: Principal Medical WriterBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...

  • Principal Medical Writer

    2 weeks ago

    Bengaluru Luxor North Tower, India GSK Full time ₹ 1,20,000 - ₹ 2,40,000 per year

    Job Title: Principal Medical WriterBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's...

  • Medical Writer

    4 days 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...

  • Medical Writer

    4 days ago

    Bengaluru, Karnataka, India MS CLINICAL Full time

    **About the job**: **Job Title**:Medical Writer** Company: MS Clinical Research Pvt Ltd Location: Indiranagar, Bangalore Experience: 2-4 years **About MS Clinical**: MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing...

  • Medical Content Writer

    2 days ago

    Bengaluru, Karnataka, India Global Healthcare Academy Private Limited Full time

    Job Title: Medical Content Writer Experience: 0-1 Year About Us: Global Healthcare Academy (GHA) is a Bengaluru-based Med-Ed Tech organization dedicated to advancing healthcare education through evidence-based, simulation-led, and skill-focused training programs. We collaborate with clinicians, academic leaders, and healthcare institutions to deliver...

  • Medical Writer

    2 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,...