Fortrea, a renowned contract research organization (CRO) with a global presence, is seeking a talented Remote Senior Safety Writer to join our team in Mumbai, India. This full-time role offers an opportunity to work remotely and make significant contributions to pharmaceutical advancements. If you're passionate about scientific writing and driving positive changes in healthcare, this position is tailor-made for you.
About Fortrea: Fortrea is a leading CRO dedicated to scientific rigor and clinical excellence. With over 19,000 staff across 90+ countries, we provide innovative solutions in clinical development, patient access, and technology across various therapeutic areas. Our commitment to transforming drug development and improving patient outcomes drives everything we do. Job Overview: As a Remote Senior Safety Writer at Fortrea, you will play a pivotal role in authoring and reviewing safety reports and regulatory documents for global submissions. Your contributions will directly impact the success of clinical trials and drug development initiatives. This position offers remote work flexibility, allowing you to collaborate with cross-functional teams and contribute to cutting-edge healthcare solutions. Responsibilities:
- Write and review safety reports for regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Benefit-Risk Evaluation Reports.
- Author regulatory documents such as Common Technical Document Summaries and Clinical Overviews.
- Conduct trainings and provide guidance to junior team members in medical writing tasks.
- Collaborate with stakeholders to address health authority questions and feedback.
- Participate in signal detection activities and prepare signal reports.
- Coordinate report writing activities across teams and ensure compliance with regulatory requirements.
- Maintain high-quality standards in document preparation and process adherence.
- Bachelor's, Master's, or Ph.D. degree in a life sciences-related discipline.
- Strong scientific writing skills and familiarity with regulatory requirements.
- Experience in drug development, medical writing, or related fields preferred.
- Excellent communication, collaboration, and organizational abilities.
- Proficiency in conducting literature searches and analyzing data.
- Ability to manage multiple tasks and meet project timelines effectively.
Why Join Fortrea: Joining Fortrea means being part of a dynamic team dedicated to revolutionizing clinical trials and healthcare delivery. As a Remote Senior Safety Writer, you'll have the opportunity to work on impactful projects, collaborate with industry experts, and contribute to life-changing therapies for patients worldwide. Our inclusive and supportive work culture fosters personal growth and professional development, enabling you to make a meaningful difference in the healthcare landscape.
Ready to embark on a rewarding career journey with Fortrea? Apply online today and be part of our innovative team driving healthcare innovations globally.
