Work Schedule
Other
Environmental Conditions
Office
Job Description
Medical Writer (India) (FSP)
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Summarized Purpose:
We are excited to expand our India Medical Writing FSP Team! We are looking for a Medical Writer to join our team in the FSP space; experience in Immunology, Oncology or Vaccines would be valuable but not essential. The writer will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Essential Functions:
- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods, and techniques for achieving optimal results.
- May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years of regulatory writing).
- Should have hands on working experience in any of CSR, Protocol, IB, Narratives, Summaries and Regulatory Submission modules
- Experience working in the pharmaceutical/CRO industry preferred.
- Experience in scientific writing advantageous.
- Experience in the therapeutic areas of Immunology, Oncology or Vaccines advantageous.
Knowledge, Skills, and Abilities:
- Solid medical writing skills, including grammatical, editorial, and proofreading skills.
- Ability to interpret and present complex data accurately and concisely.
- Effective administrative, organizational, and planning skills; attention to detail and quality
- Ability to work on own initiative and effectively within a team.
- Effective oral and written communication skills
- Good knowledge of regulatory documentation and drug development process
- Great judgment and decision-making skills
- Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.