Fortrea Hiring for Principal Safety Writer
Are you passionate about clinical development, regulatory writing, and making a real impact in the healthcare sector? Fortrea, a global leader in contract research, is on the lookout for a Principal Safety Writer to join their team in Mumbai. This exciting opportunity is perfect for those looking to contribute to life-saving therapies and be part of a world-class organization at the forefront of medical and drug development.
Quick Overview
| Job Title | Principal Safety Writer |
|---|---|
| Hiring by | HR Dipika Karad |
| Company | Fortrea |
| Location | Mumbai, India |
| Experience Required | 2 Years |
| Salary | Not disclosed |
| Job Type | Full-time |
| Posted on | October 2, 2024 |
Why Fortrea?
Fortrea is a globally recognized Contract Research Organization (CRO), with a mission to revolutionize drug and medical device development. They work in over 90 countries, specializing in comprehensive clinical development, patient access, and innovative technology solutions. With a team of 19,000 talented professionals, Fortrea is shaping the future of healthcare by accelerating the delivery of life-saving treatments. Fortrea Hiring for Principal Safety Writer
If you’re someone who thrives in a fast-paced, innovative environment and has a passion for scientific writing, this could be the next big step in your career.
Your Role as a Principal Safety Writer
As a Principal Safety Writer at Fortrea, you will play a pivotal role in regulatory and safety reporting, ensuring that crucial safety data reaches the right authorities on time. You’ll be responsible for producing high-quality safety documents, guiding teams of writers, and acting as a liaison with clients. Your day-to-day tasks will involve: Fortrea Hiring for Principal Safety Writer
- Creating Safety Reports: Writing and reviewing reports for global regulatory submissions, including but not limited to Annual Reports (IND), Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), and Medical Device Reports.
- Leadership: Managing the entire process of report production while overseeing the quality and ensuring deadlines are met. You will also mentor junior writers and offer valuable feedback.
- Client Interaction: As the key point of contact for clients, you’ll handle all report-related activities, addressing challenges and ensuring smooth project delivery.
- Risk Management Plans (RMPs): You’ll be responsible for authoring and reviewing RMPs, Benefit-Risk Evaluation reports, and documents related to pharmacovigilance activities.
- Collaboration and Analysis: Participate in signal management processes, collaborating with cross-functional teams to provide safety analysis and recommend risk mitigation measures.
- Health Authority Responses: Drafting responses to health authority queries and working closely with teams to manage feedback from regulatory bodies.
- Scientific Publications: Contribute to the development of scientific literature, including abstracts, posters, and manuscripts intended for healthcare professionals.
- Training and Mentorship: Provide coaching and training to other writers on best practices in regulatory writing.
- Business Development: Support the company’s growth by estimating resource needs for projects and assisting in proposals for new business opportunities. Fortrea Hiring for Principal Safety Writer
Qualifications
To excel in this role, you should have:
- Regulatory Writing Expertise: Proven experience in regulatory writing and safety reporting, particularly with health authorities.
- Strong Leadership: The ability to manage teams, offer guidance, and communicate effectively with both clients and team members.
- Technical Knowledge: A solid understanding of safety databases, regulatory guidelines, and signal management processes.
- Scientific Writing: Excellent communication skills with a knack for clear, concise scientific writing.
Why This Role is Perfect for You
This is a career-defining opportunity for experienced safety writers looking to expand their expertise within a top-tier global organization. Not only will you gain exposure to diverse regulatory environments across the globe, but you’ll also be contributing directly to life-saving research and medical breakthroughs. At Fortrea, your work matters. You’ll be part of a company that’s genuinely committed to improving patient outcomes and supporting the next generation of medical innovations. Fortrea Hiring for Principal Safety Writer
If you are a proactive, detail-oriented individual with a passion for regulatory writing and the ability to lead and mentor teams, this is your chance to shine. Apply now and become part of a dynamic team that is making a difference worldwide. If you are a proactive, detail-oriented individual with a passion for regulatory writing and the ability to lead and mentor teams, this is your chance to shine. Apply now and become part of a dynamic team that is making a difference worldwide.
Application Link
Ready to Make a Difference?
Fortrea is seeking talented professionals who are ready to take on exciting challenges in the world of clinical research and regulatory writing. If you have the drive and the experience, don’t miss out on this opportunity to join one of the most respected organizations in the CRO industry. Apply today!