SANOFI is hiring Senior Medical Regulatory Writer
Sanofi, a renowned pharmaceutical company, is currently seeking a highly skilled and experienced Medical Regulatory Writer to join their team in Hyderabad on a full-time basis. With an advanced degree in life sciences, pharmacy, or a related field, along with a strong background in regulatory writing within the pharmaceutical or healthcare industry, you will play a crucial role in producing high-quality clinical and safety documents.
Location : Hyderabad
Company : Sanofi
Role : Senior Medical Regulatory Writer
Time type : Full time
Job requisition id : R2674080
Education: Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D. – master’s in science)
Main responsibilities of Senior Medical Regulatory Writer role :
Write and/or edit high-quality clinical and safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), ID Cards, and evaluation reports, with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards.
Essential Job duties and responsibilities:
1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
2) Develops and maintains TA
expertise.3) Reviews content created by peers’ writers.
4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, and Pharmacovigilance teams.
People:
1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.
2) Interact effectively with stakeholders in medical and pharmacovigilance departments.
3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance: Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA) as per agreed timelines and quality
Process:
1) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
4) Work with selected vendors within the region to deliver the required deliverables as per the defined process.
5) Design an overall plan of action basis end-customers feedback & improve course content and delivery.
Stakeholders:
1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
2) Liaise with the Medical department to prepare relevant & customized deliverables.
Experience required for the Senior Medical Regulatory Writer role: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment
Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills)
Education: Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D. – master’s in science)
Languages: Excellent knowledge of the English language (spoken and written)
ABOUT THE COMPANY
Sanofi emphasized that diversity and inclusion are fundamental to their operations and are deeply ingrained in their Core Values. They acknowledged that in order to fully benefit from the valuable contributions diversity offers, they must prioritize inclusion and cultivate a work environment where these differences can flourish and be utilized to enhance the well-being of their employees, patients, and customers. The company expressed their profound respect for and celebration of the diverse individuals within their workforce, recognizing their various backgrounds and experiences, and ensuring equal opportunities for everyone.
CHECK OUT RASAYANIKA FOR MORE UPDATES
Here are few interview question and answers for the Senior Medical Regulatory Writer role at SANOFI:
1: Can you describe your experience in medical regulatory writing and how it aligns with the requirements of this role at Sanofi?
Answer: I have over five years of experience in regulatory writing within the pharmaceuticals/healthcare industry. During this time, I have been involved in writing and editing various clinical and safety documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports, and evaluation reports. I have a strong understanding of internal and external standards and ensure the delivery of high-quality medical documents within specified timelines. My expertise also extends to collaborating with cross-functional teams such as Scientific Communication, Medical Regulatory Writing, and Pharmacovigilance. Overall, my experience has equipped me with the necessary skills to excel in this role at Sanofi.
Interview Question 2: How do you maintain effective relationships with stakeholders, particularly within the medical scientific community, to develop medical regulatory content?
Answer: Building and maintaining effective relationships with stakeholders, especially within the medical scientific community, is crucial for successful medical regulatory writing. I prioritize clear and open communication to understand their requirements and expectations. I actively listen to their feedback and address any concerns promptly. I also make an effort to stay updated with the latest advancements in the field to ensure the content I develop aligns with their needs. By demonstrating professionalism, responsiveness, and a genuine interest in their work, I establish trust and foster collaborative partnerships.
Interview Question 3: Can you share an example of a time when you had to work independently in planning analysis and data presentation for a project? How did you ensure the successful completion of the task?
Answer: In a previous role, I was assigned to independently plan the analysis and data presentation for a clinical study report. To ensure a successful completion of the task, I first thoroughly reviewed the study data and familiarized myself with the study objectives and outcomes. I then developed a detailed plan, including the key analysis points and the most appropriate ways to present the data. I sought feedback from the mentoring medical writer to validate my approach. Throughout the process, I maintained clear communication with the cross-functional team, seeking their input and addressing any questions or concerns. By diligently following the plan and incorporating feedback, I successfully completed the analysis and data presentation, meeting the project’s objectives and timeline.
Interview Question 4: How do you stay updated with regulatory requirements and maintain expertise in medical regulatory writing?
Answer: Staying updated with regulatory requirements and maintaining expertise in medical regulatory writing is essential for ensuring compliance and delivering high-quality content. I actively engage in continuous learning and professional development opportunities, such as attending conferences, webinars, and workshops focused on regulatory writing and related areas. I also keep myself informed about the latest regulatory guidelines, industry trends, and best practices through regular reading of relevant publications and participation in professional forums. Additionally, I leverage my network of peers and industry contacts to exchange knowledge and stay informed about emerging regulations and changes in the field. By prioritizing ongoing learning, I ensure that my expertise remains current and relevant.
ALL THE BEST !
