Senior Regulatory Medical Writer - India
Location
Bangalore | India
Job description
Description
Premier Consulting, a division of Premier Research, is seeking a
Senior Medical Writer . Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.
What You'll Be Doing - Independently write and format clinical and regulatory documents
- Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents)
- Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project
- Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients
- Interpret and summarize clinical data as needed to prepare documents
- Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals
- Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents
What We're Searching For - Bachelor's degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
- BA/BS and 6-10 years of experience in medical/regulatory writing; or MS and 4-6 years of experience in medical/regulatory writing; or PhD and 2+ years of experience in medical/regulatory writing
- International experience desirable
- Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
- Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets
- Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports
Why choose Premier Research - Premier Research is more than a company – it's a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our
staff with innovative technologies and continuous learning opportunities so that they
have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse
population, we require the perspectives of a diverse staff thinking creatively, challenging ideas,
and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion,
and empowerment, we create a community of belonging that welcomes differences, fuels
innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
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