Safety Medical Writer

  Medical Writing

Job title: Safety Medical Writer

Company: Novo Nordisk

Job description: Job description Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitu

Job description Does your motivation come from challenges and working in a dynamic environment Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential Do you have a can-do attitude with continuous improvement as one of your career objectives Then we might have the right position for you. We are looking for Safety Medical Writer in Global Safety unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level. About the department Global SafetyGlobal Business Service (GS-GBS) was set up in 2010 as one of the hub for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring. The position As a Safety Medical Writer, you would be involved to plan, drive, and co-ordinate preparation of safety documents to ensure submission according to agreed timelines. You will prepare Development and Periodic Safety Update Reports (DSURs and PSURs) in collaboration with relevant stakeholders for submission worldwide. Further, you would be responsible to initiate and prepare updates of Clinical Risk Management Plans in collaboration with relevant stakeholders for regulatory submissions worldwide and ensure consistency between this document and other relevant clinical documents. You will also perform consistency review of documents as a back-up SMW. You are expected to actively contribute to knowledge sharing, skill building and good collaboration with stakeholders and colleagues. Your task will involve maintaining a good working relationship with stakeholders and colleagues, and contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge. You will maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas. Also, actively participate in relevant meetings, training sessions and seminars in the department and ensure that documents are in accordance with Novo Nordisk SOPs and external guidelines. Below skills are required: Any graduate with Pharma/ Healthcare/ Life science background i.e BSc, Bpharm, MPharm, PhD Or equivalent 2+ Years of relevant working experience within some of the key professional competencies Clinical/CRO/Pharma Industry Strong understanding of Microsoft office package (Outlook, Word, Excel and PowerPoint) Strong verbal and written communication Strong analytical skills Professional authority Quality mind-set, well-organised and strive for excellence Pro-active planner to meet agreed deliverables Strong communicator (verbally and in writing) Curious and constantly looking for improvement opportunities Team player with high degree of flexibility and service mindedness Cross-cultural awareness Ability and willingness to quickly adjust to changes in a continuously developing environment Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please contact [HIDDEN TEXT] Deadline 7 April 2022 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 09 Mar 2022 23:27:39 GMT

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