Senior Medical Information Writer

Sanofi; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Sanofi Global Hub in India is seeking a seasoned medical writer to research, author and edit scientific response documents under the Global Medical Information team. You will adapt global materials for multiple countries, support US NDA reports and contribute to peer reviews while maintaining therapeutic area expertise.

Requirements include 5+ years in pharma medical writing, strong editing/writing skills, and fluent English.

Qualifications

• 5+ years of medical writing experience in pharma or clinical setting.
• At least 2-3 years of direct medical information experience in a pharmaceutical company.
• Excellent English language skills.

Responsibilities

• Conduct literature searches and summarize data from the scientific literature.
• Generate evidence-based, accurate, current, and fair-balanced summaries for scientific response documents.
• Adapts global scientific response documents for assigned countries.
• Develops responses to escalated inquiries for assigned countries.
• Develops contributions to US NDA Annual Reports.
• Contributes to US compendia reviews.
• Contributes to peer reviews.
• Collaborates with cross-functional project teams and ensures timely completion of projects.
• Develops and maintains Therapeutic Area expertise.
• Reviews content created by peer writers.
• Collaborates with Global Medical Information teams to execute content plans.

Skills

Literature search

Medical writing

Editing

Document management

Stakeholder management

Time management

Risk management

Scientific writing

Communication skills

Education

Advanced degree in life sciences/pharmacy/related

Job description

Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency.

Essential Job duties and responsibilities:

• 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature.
• 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s).
• 3) Adapts global scientific response documents for assigned countries.
• 4) Develops responses to escalated inquiries for assigned countries.
• 5) Develops contributions to US NDA Annual Reports.
• 6) Contributes to US compendia reviews.
• 7) Contributes to peer reviews.
• 8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule.
• 9) Develops and maintains Therapeutic Area expertise.
• 10) Reviews the content created by peer writers.
• 11) Collaborates effectively with Global Medical Information teams to execute content plans.

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 information content as per requirement.
• 2) Interact effectively with stakeholders in medical and pharmacovigilance departments.
• 3) Constantly assist other medical information writers in developing knowledge and sharing expertise.

Performance:

Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality

Process:

• 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported.
• 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis.
• 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries.
• 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.

About you Experience:

>5 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 2-3 years of direct medical information experience in a pharmaceutical company

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, Knowledge about literature evaluation and multilevel response development)

Education:

Advanced degree in life sciences/ pharmacy/ similar discipline, or medical degree or doctorate degree (PharmD, Ph.D, Master in science, MBA or equivalent)

Languages:

Excellent knowledge of the English language (spoken and written)

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.