Senior Medical Regulatory Writer

Are you a highly skilled and experienced Medical Regulatory Writer looking for a new and exciting opportunity? Look no further than Sanofi! We are seeking a motivated and detail-oriented Senior Medical Regulatory Writer to join our dynamic team. In this role, you will have the opportunity to use your expertise to support the development and submission of regulatory documents for our innovative medical products. As a Senior Medical Regulatory Writer at Sanofi, you will play a crucial role in ensuring the accuracy and compliance of our regulatory documents, ultimately contributing to the success of our company and the well-being of patients. If you have a strong background in medical writing and are passionate about making a difference in the pharmaceutical industry, we want to hear from you!

1. Write and edit regulatory documents such as clinical study reports, investigator brochures, and regulatory submissions in accordance with company and regulatory guidelines.
2. Collaborate with cross-functional teams to gather and analyze data, ensuring accuracy and completeness of information.
3. Stay updated on relevant regulations and guidelines to ensure compliance in all written materials.
4. Work closely with subject matter experts, clinical teams, and other stakeholders to develop and review documents.
5. Manage timelines and prioritize workload to ensure timely completion of documents.
6. Conduct literature searches and review scientific literature to support document development.
7. Participate in meetings and discussions to provide input on document content and strategy.
8. Maintain document templates and style guides to ensure consistency and adherence to company standards.
9. Provide guidance and support to junior writers and review their work for accuracy and quality.
10. Communicate with regulatory agencies as needed to address any queries or concerns related to documents.
11. Identify and implement process improvements to enhance efficiency and quality of document development.
12. Ensure all documents are of high quality and meet internal and external standards.
13. Comply with company policies and procedures, including those related to data privacy and confidentiality.
14. Contribute to the development of new products by providing input and support on regulatory writing aspects.
15. Serve as a subject matter expert and resource for colleagues and stakeholders on medical writing and regulatory requirements.

According to JobzMall, the average salary range for a Senior Medical Regulatory Writer in Hyderabad, Telangana, India is between ₹ 9,00,000 to ₹ 12,00,000 per year. However, this can vary depending on the specific company, experience level, and skills of the individual. Some companies may offer higher salaries for more experienced writers or for those with specialized skills, while others may offer lower salaries for entry-level positions. It is also important to consider factors such as benefits, bonuses, and other forms of compensation when evaluating a job offer.

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.