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Regulatory Consultant/Sr. Consultant RIM

Regulatory Consultant/Sr. Consultant RIM

Syneos Health

8 - 13 years

25 - 30 Lacs

gurugram

Posted:2 days ago| Platform:

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Skills Required

career development medical affairs process optimization publishing agile clinical development http stakeholder management user acceptance testing recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Consultant/Sr. Consultant - RIM/Veeva Business Analyst (US timeshift)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern ket realities.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, in ating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Job Responsibilities

General Responsibilities :

Look for system/process-focused analysts with RIM/Veeva experience.
Excellent communication and stakeholder management skills.
Master s degree with overall 8+ years experience
Experience in system requirement gathering, validation, and user acceptance testing.
Ability to collaborate across cross-functional teams (Reg Ops, IT, Process Development etc).

Note:

Exclude candi whose experience is limited to regulatory publishing/submissions.
Availability in EST timezone for collaboration purposes.

Core Responsibilities:

Act as the pri y liaison between Regulatory Operations teams and IT/Tool Management teams.
Focus on technology enablement and process optimization.
Gather and document requirements from key users (business partners, RIM superusers, technical leads).
Ensure requirements are maintained and up in alignment with business needs.
Collaborate with DTE and Validation teams.
Support user testing activities, including preparation of test scripts and execution oversight.
Serve as SME for RIM systems.
Provide guidance, communication, and training to users on business tools and processes.
Work closely with IT and process development teams to manage RIM system enhancements.
Collaboration with global teams to coordinate system inputs, vali data, resolve missing fields or gaps, and support end-to-end system workflows.
Contribute to continuous improvement initiatives.

Over the past 5 years, we have worked with 94% of all el FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Syneos Health

Biotechnology Research

Morrisville NC

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Regulatory Consultant/Sr. Consultant RIM