Drug Safety Associate-Entry Level-Across US

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Title:

Drug Safety Associate-Entry Level-Across US

Job ID:

89505

Location:

Bridgewater, NJ 

Classification:

Administration, Education & Training, Healthcare & Community, Hospitality & Tourism

Salary:

40-47

Salary Type:

per hour

Posted By:

The Veritas Healthcare Solutions LLC
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Job Type:

Full time

Posted:

07/13/2019

Start Date:

-

Telephone:

646-907-4086
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Job Description:

Drug Safety Associate

The Veritas Healthcare Solutions LLC is a rapidly growing Healthcare training and consulting company and we are currently looking for aspiring individuals to be trained and placed in Validation/DSA/PV/CRA/CDM/CDA/BA/QA. We offer Free online trainings and placement in respective fields. 

Visa Benefits provided for H1B, OPT, STEM OPT, CPT candidates.

The main responsibility will include monitoring and tracking regulatory information and assuring accurate communication of the current status of post-approval change control assessments and submissions; ensures all databases are up-to-date and accurately reflects registered information. 

Scope of Responsibilities:
  • Support global regulatory submissions such as annual reports, PAS, CBE supplements, variations, registration renewals, response dossiers, etc.
  • Interacts with RA colleagues world-wide;
  • May provide project team representation while working closely with site Manufacturing, Quality, Technical Support/service groups to compile required information in accordance with established timelines;
  • Coordinate and work with sites to prepare regulatory document packages to support post-market changes
  • Provides project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.
  • Review technical documentation (i.e., Change Controls); Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals;
Must Have Skills/Experience:
  • Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
  • Strong understanding of manufacturing processes
  • Excellent organizational skills, demonstrated ability to prioritize multiple projects.
  • Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
  • Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products
  • Ability to effectively interpret guidance and provide recommendation to key stakeholders.
  • Regulatory, Manufacturing, QA/QC experience
  • Proficient in MS Word, Excel, PowerPoint, MS Project
  • Ability to set ambitious and realistic targets, drive for results and build accountability.
  • Ability to effectively manage the balance between delegation/empowerment and a hands-on approach
Education/Training:
  • BS, MS or PhD in Biology, Chemistry or related field.
  • Bachelors or Master’s degree in the Life Sciences and  experience in regulatory, manufacturing, technical development or QA/QC
  • In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.

BENEFITS:

E-verification and initial OPT & STEM extension assistance.

H1b & GC sponsorship.

Relocation benefits.

Health benefits.

 

Interested candidates kindly send us your most recent resume.

Company Info
The Veritas Healthcare Solutions LLC 469 7th Ave
New York, NY, United States

Email: careers@theveritashealthcare.com
Phone: 646-907-4086
Web Site: http://www.theveritashealthcare.com/

Company Profile