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 : Associate Clinical and Safety Publisher
Job Description
About the department
The Medical Writing unit has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. It is a dynamic mix of young, enthusiastic, qualified, and skilled Medical Writers and Publishers who are full of commitment, passion, skills and talent. The team is a right blend of professionals with Masters/PhD in pharmacology, medicine, toxicology etc. with broad background knowledge on different therapeutic areas and medical basics. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications.
The position
• As an Associate Safety and Clinical Publisher, you will be responsible to perform compilation and publishing of clinical and safety documents including Clinical Trial Reports (CTRs) and Non-intervention Study Reports (NSRs), safety surveillance reports (PSURs, DSURs, Clinical Risk Management Plans etc.) and documents as required in accordance with current Novo Nordisk standards (SOPs) and guidelines for regulatory publishing. You will create assemblies in ePub as applicable and in accordance with NN standards for regulatory publishing and perform additional processing of published documents. You will ensure finalisation documents; legacy documents are indexed into EDMS for regulatory submissions as applicable and distribution of final documents according to valid SOPs.
• You will be expected to plan and coordinate the collection of appendix material in collaboration with the medical writer, relevant document contributors (study groups) and local affiliates. You will also ensure quality of appendices of clinical documents by ensuring proactive and timely identification and escalation of issues and format of documents, proactive communication of knowledge and expertise to relevant stakeholders and support document owners and checking appendix documentation to ensure completeness, GCP compliance, and adherence to internal SOPs and regulatory publishing standards.
• You will ensure quality deliverables of Non-clinical reports by performing eCTD checks of reports including but not limited to Non-clinical CRO Reports, Non-clinical Section Reports for Clinical Trial Reports, Non-clinical Principal Investigators Reports, Clinical CRO Reports for Clinical Trial Reports etc. according to internal PDF check list. You will make sure that all workflows, procedures, checks, and guidelines are followed based on the report type and in compliance with NN QMS and ensure quality control of the Non-clinical Reports and timeliness of the eCTD checks with focus on stakeholder and organisational requirements.
• You will be responsible to secure collaboration and stakeholder engagement with colleagues globally, and contribute to self-development and knowledge sharing within the team. You will actively participate in relevant meetings, training sessions and seminars in the team to develop and update the knowledge on publishing.
Candidate Profile
• Post-graduate (Pharmacy, Life sciences)
• Minimum 6 months of relevant experience in the routine use of Document Management Systems, MS Office, Portable Document Format (PDF) tools including Adobe Acrobat Professional and ISI toolbox
• General knowledge and understanding of FDA, ICH and other regulatory electronic documentation requirements
• Strong Team player with a high degree of flexibility
• Systematic and organised
• Ability to communicate, plan and coordinate multiple simultaneous activities
• Excellent communication and stakeholder management skills
• Analytical, solution oriented and ability to multitask and prioritize activities
• Ability to communicate with people from different professional and cultural backgrounds
Additional Information
Qualification : Post-graduate (Pharmacy, Life sciences)
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical and Safety
End Date : 28th February, 2022
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