Hyderabad, IND
2 days ago
Senior Medical Information Writer
**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 activitie_ _s. 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) Develops and maintains Therapeutic Area expertise. 8) Reviews the content created by peer writers. 9) 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, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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