--Must See--
BSc Life Science Regulatory Affairs Officer Role at IQVIA – Apply Online
Associate Regulatory Affairs Officer
Bengaluru, India
Full time
R1440159
Job Description
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 the 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.
Apply for this position here
