Our passion for science and technology is what drives our around 63,000 employees in 65 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live. We are here for people at every step, helping to create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services and digital platform make research simpler, more exact, and help deliver breakthroughs more quickly. Our solutions accelerate access to health by assuring tests are accurate and the medicine we take can be trusted. We are the company behind the companies, advancing digital living. Our science sits inside technologies that are changing the way we access, store, process, and display information.
Post : Senior specialist / Expert Medical Writer
Job Description
As a Senior Specialist/ Expert Medical writer , you will support the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels.
• Independently prepares of clinical and regulatory documents such as Protocols, Clinical Study Reports, or Investigator Brochures.
• You will also be responsible for supporting submissions for market approval/line extensions under minimal supervision.
• Proactively contribute to the development and implementation of MW best practices and process improvements.
• May Oversee and coordinate other (external) writers assisting on documents under your responsibility, ensuring strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
• Ensure that all documents are produced according to agreed timelines, adhere to relevant SOPs, and meet the requirements of regulatory authorities and the company.
• Participate in meetings related to key MW, QC, and compliance activities.
Candidate Profile
• Graduate or post graduate degree in BPharm/MPharm, PHD, BDS (Dental), BSC/MSC or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
• Regulatory medical writing experience (4 to 9 years)
• Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
• Knowledge of Clinical and Regulatory documents
Additional Information
Experience : 4 to 9 years
Qualification : BPharm/MPharm, PHD, BDS (Dental), BSC/MSC
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th January 2025
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