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Pharmacy Regulatory Affairs Publisher
New York, NYJob Title: Pharmacy Regulatory Affairs Publisher
Position Type: 11+ Months
Location: Remote
Vertical- Life Sciences
Job Description The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and US Submissions.
• Performing final technical quality review.
• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
• Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
• Co-ordinate with client/stakeholders
• Project Management skills
Minimum qualifications
• B. Pham/M.Pharm/Science Graduate
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.
• Veeva Vault Experience
• Effective time management and organizational skills
• Effectively communication
• Flexibility to adapt to a changing environment
• Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Preferred Qualifications
• Proven rich experience in Pharmacy Regulatory Affairs
Regards,
Rahul Yadav
(408) 560-3956
rahul@reqroute.com
http://reqroute.catsone.com/careers/index.php (Click to see MOST Current Openings)
DISCLAIMER: The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer or if you want to be REMOVED please reply with REMOVE in the Subject line of this email
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law (www.reqroute.com). We are committed to providing exceptional experience. To give feedback please email us at support@reqroute.com.
Position Type: 11+ Months
Location: Remote
Vertical- Life Sciences
Job Description The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and US Submissions.
• Performing final technical quality review.
• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
• Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
• Co-ordinate with client/stakeholders
• Project Management skills
Minimum qualifications
• B. Pham/M.Pharm/Science Graduate
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.
• Veeva Vault Experience
• Effective time management and organizational skills
• Effectively communication
• Flexibility to adapt to a changing environment
• Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Preferred Qualifications
• Proven rich experience in Pharmacy Regulatory Affairs
Regards,
Rahul Yadav
(408) 560-3956
rahul@reqroute.com
http://reqroute.catsone.com/careers/index.php (Click to see MOST Current Openings)
DISCLAIMER: The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer or if you want to be REMOVED please reply with REMOVE in the Subject line of this email
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law (www.reqroute.com). We are committed to providing exceptional experience. To give feedback please email us at support@reqroute.com.
Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)