Expert Medical Information writer

Job description

Job title : Expert Medical Information writer

·  Hiring Manager: Head of Scientific Communications
·  Location: Hyderabad
·  % of travel expected: Travel required as per business need
·  Job type: Permanent and Full time

About the job

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:

Write and/or edit high-quality scientific response documents independently under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance, acting as an SME on different types of response documents and other GMI activities. Proficient understanding of Medical Information achieved through a combination of product knowledge, along with editing, writing, and document management.

Essential Job duties and responsibilities: 1) Proficient in Conducting literature searches and reviews; and extracting/ summarizing complex data from the scientific literature. 2) Works with minimal guidance to generate evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in multiple therapeutic areas, develops US FDA Annual Reports, and reviews compendia. 3) Ability to produce medical documents according to all Sanofi relevant global guidelines, country guidelines and policies. 4) Acts as a Subject Matter Expert maintaining expertise in the processes, templates, and guidelines, and key deliverables aligned with the key trends and developments in the industry. 5) Constantly assist other medical information writers in developing knowledge and sharing expertise (on key deliverables, processes, templates, and guidelines). 6) Agile and knowledgeable to be able to work across different therapeutic areas and new deliverable types. 7) Demonstrates resolve and urgency to accomplish tasks and liaise with cross-functional project teams as needed.  8) Ensure that assigned projects are completed on schedule. 9) Demonstrates a deep understanding and/or experience of working in a regulated GXP environment

·  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: 1) Provide SME support and high-quality completion of deliverables (local and custom scientific response documents, US FDA Annual Reports, and Compendia Reviews) as per agreed timelines and quality. 2) Supports delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards with the agility to learn and contribute to situations of demands. 3) Ability to multi task and manage different type of projects simultaneously.
·  Process: 1) Act as an expert in the field of medical information writing with project management skills and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting 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. 6) Capable of identifying risks to processes and proposing mitigation plans through the application of a problem-solving mindset.
·  Stakeholders: 1) Work closely with medical teams in countries/regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with the Global Medical Information team and country medical information teams as relevant.

About you

·  Experience : ≥8 years of experience in content creation in medical or scientific writing for the pharmaceuticals/healthcare industry, or equivalent experience in the clinical setting, pharmacovigilance; At least 4 years of direct medical information writing experience in the pharmaceutical company; Minimum 2 years of experience in managing global, cross-functional project teams, working in a Matrix environment, and acting as an SME, mentor or guide.
·  Soft skills : Excellent communication skills (written, verbal, and presentation), Stakeholder management; and ability to work independently and within a team environment.
·  Technical skills : As applicable (Including but not limited to Expert knowledge of medical information documents including Response documents, Compendia review and FDA Annual Reports, Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development). Understanding of the local country legal requirements with regards to Medical Information document provision for customers including health care professionals, patients, carers and other relevant decision makers (such as ABPI Code of Practice for UK) is desirable.
·  Education : Advanced degree in life sciences/pharmacy/similar discipline (Ph.D., Master, or bachelor’s in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
·  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 !

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.