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.
Post : Senior Disclosure Medical Writer
• Your key responsibilities is to perform all disclosure medical writing tasks independently and contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge. Also, you should maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas.
• Some of the main tasks to perform disclosure medical writing tasks includes preparation/review and timely submission of Protocol registration, results disclosure of clinical trials, German synopsis, redacted clinical documents, justification tables and anonymization reports as per different regulatory policies, publication requirements (ICMJE) and organization policies.
• You will be doing the Quality control of the redacted CTRs and results tables/Data Sets/synopses to the clinical trial registries world-wide.
You will also be ensuring and driving the skill development and enhancement for securing quality deliverables and right level of competencies in the team. You will be actively participating in relevant meetings, training sessions, seminars, projects and internal/external marketing/medical activities.
• You will drive and contribute to continuous process improvements, efficiency initiatives and quality mindset. You will always ensure audit readiness and participate from conduct till closure of the audits.
• You will act as a Subject Matter Expert on Disclosure deliverables. You will Support the manager in planning and managing upcoming disclosure deliverables and resourcing requirements.
• The job requires good communication and analytical skills. In order to meet timelines, the Senior 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 GBS as well as within GD, HQ.
• Graduate (PhD, MSc., M Pharm, MD, BDS, or equivalent)
• ≥ 4 years of experience of evaluation and communication of data preferably from the pharmaceutical /CRO industry
• Experience with clinical drug development, GCP and relevant regulatory requirements in relation to clinical trials registration and transparency, especially the EudraCT and CT.gov related requirements
• Experience working within a global setting
• Experience with clinical trial methodology
• Experience from working in a project orientated, international organization
• Experience in working on IT tools in disclosure and transparency area
• Strong analytical skills
• Committed, persistent and accountable
• Able to manage variable work load and handle numerous tasks simultaneously
• Able to plan and coordinate complex disclosure tasks Systematic and organized
• Recognizes problems; may need advice to solve
• Prioritizes own tasks but may need to seek advice
Experience : ≥ 4 years
Qualification : PhD, MSc., M Pharm, MD, BDS
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 30th March, 2021
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