Sr Reg Doc Coord job opportunity at IQVIA Holdings, Inc..

Home Jobs In India Tag: Job Sr Reg Doc Coord position at IQVIA Holdings, Inc.


DatePosted 3 Days Ago bot
IQVIA Holdings, Inc. Sr Reg Doc Coord
Experience: General
Pattern: full-time
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degreeGeneral
loacation Bangalore, India, India
loacation Bangalore, Ind..........India

RESPONSIBILITIES •    The Junior Publisher is responsible for supporting the compilation, publishing, and technical quality control of Regulatory submissions  •    Supports production of high-quality dossiers by handling the collection of components, publishing / assembly, quality review, and delivery of submissions in paper and electronic format (like NeeS, eCTD, etc.).  •    Supports electronic submissions, performs bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines. •    Assists with the collection of CSR appendices in accordance with ICH guidelines and IQVIA standard practices, with guidance from the lead medical writer for the CSR •    Interacts with internal clients. May have some external interactions, mostly directed by senior staff •    Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff •    Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing/regulatory submissions •    Complies with Company SOPs and participates in the implementation of new SOPs REQUIRED KNOWLEDGE, SKILLS AND ABILITIES •    Basic knowledge of clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs) or the ability and willingness to gain this knowledge. •    Strong communication skills (verbal, written and aural).  •    Strong organizational skills and time management skills. •    Proficient in Microsoft office and web-based applications.  •    Attentiveness to detail and accuracy; ability to maintain quality standards.  •    Ability to follow instructions/guidelines, utilize initiative and work independently.  •    Proven ability to multi-task, manage competing priorities and deadlines.  •    Willingness and aptitude to learn new skills. •    Self-motivated and flexible.  MINIMUM REQUIRED EDUCATION AND EXPERIENCE •    Bachelor’s degree in a life science-related discipline, preferred understanding of Regulatory Affairs in general, Publishing. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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