Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post : Senior Medical Writer
Job Description
Your key responsibilities is to perform medical writing tasks including clinical trials disclosure activities, perform publication planning tasks and contribution to knowledge sharing and good collaboration with stakeholders and colleagues world-wide. Some main task includes to perform medical writing tasks - including preparation of: Clinical trial reports (CTRs), Clinical trial results presentations for distribution to clinical investigators, Investigator’s brochures (IBs, IB updates, and the clinical sections of IMPDs/INDs - key documents for initiating new trials, Clinical summary documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorization applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), Redaction of CTRs and QC of the redacted CTRs. Results tables/Data Sets/synopses to clinical trial registries (ct.gov, EUCTR, pharmanet.bund etc) You will also have to perform publication planning tasks: Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals),to liaise with the CMRs’ medical/marketing functions on local publication activities and other relevant ad-hoc documents. Your Contribution to knowledge sharing, skill building and good collaboration with stakeholders and colleagues, participate in internal/external marketing/medical activities, e.g., expert meetings, lectures and conferences, contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge, contribute to process improvements, maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas, actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s), and maintain a good working relationship with stakeholders and colleague. Some other areas of responsibility is the tasks will to a large extent be performed independently in agreement with the immediate superior and Clinical Reporting. The medical writer will act as project manager for the task in question, and in accordance with project goals, Novo Nordisk SOPs and applicable internal and external requirements.The job requires good communication and analytical skills. In order to meet timelines, the medical writer must be good at planning own work, and be proactive when problems arise and seek help and advice from relevant people within GD GSC as well as within GD, HQ.
Candidate Profile
Hold a gaduate (PhD, MSc., M.Pharm, MD, DDS,DVM or equivalent) degree with less than or equal 4 years of experience with scientific research methodology, including designing and conducting experiments, and analysing and reporting experimental results and experience with scientific writing in English (publications for peer reviewed journals or equivalent), experience working within a global setting. You should also have strong understanding of external requirements related to regulatory documents , experience from the pharmaceutical /CRO industry, relevant experience with drug application processes to FDA and EMEA. We expect you to be open and honest, proactive, have good communication skills and excellent written and spoken English. You should have the ability to handle numerous tasks simultaneously, ability to mentor junior members of the team, be systematic and organized, analytical and a good team player within an international, multi-cultural environment.
Additional Information
Experience : 4 years
Qualification : PhD, M.Sc., M.Pharm, MD
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare
Functional Area : Clinical Development
End Date : 25th December, 2018
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