14 days old

Senior Regulatory Operations Specialist

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    115262683
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

The Regulatory Operations Specialist/Sr Specialist is responsible for document-level publishing, submission level publishing in eCTD and other electronic formats, and support for ACADIA Regulatory Affairs systems. Under moderate supervision, the Regulatory Operations Specialist/Sr Specialist works with team members in Regulatory Affairs and other functions to deliver timely and technically valid electronic submissions. As needed, the Regulatory Operations Specialist/Sr. Specialist will participate in systems projects by supporting requirements definition, testing, data migration, and training.

Primary Responsibilities:

  • Performs document-level publishing tasks including formatting, bookmarking, and QC (publishing-focused)
  • Performs report-level publishing for complex documents including nonclinical reports, clinical study reports, PADERs, and DSURs
  • Independently publishes routine submissions to ACADIA INDs and NDAs including but not limited to: general correspondence, protocol amendments, information amendments, and annual reports/PADERs/DSURs
  • Works with senior regulatory operations team members, submission managers, and other team members to publish and coordinate QC of large submissions including but not limited to: original NDAs and supplements, original INDs and major information amendments, responses to health authority questions
  • On an as-needed basis provides training and support to users within Regulatory Affairs and other ACADIA functions on systems including Veeva Vault RIM and IQVIA RIM Smart
  • On an as-needed basis develops and maintains work instructions related to document/report/submission publishing and QC and archiving
  • Works with team members to support system implementation and upgrades. Specific tasks may include assistance in defining requirements, development and execution of test scripts, and migration of data and documents
  • As needed, review health authority guidance to determine impact to ACADIA Regulatory Operations processes

Education/Experience/Skills:

  • Bachelors degree in a scientific discipline, information technology, or business administration preferred
  • Minimum of 5 to 8 years experience in Regulatory Affairs or related function
  • With moderate supervision, demonstrated ability to prioritize work, escalating concerns to management as needed
  • Understanding of eCTD and electronic publishing concepts (e.g., lifecycle management, metadata, bookmarking and hyperlinking)
  • Prior experience with eCTD/electronic publishing systems (e.g., IQVIA RIM Smart, Extedo eCTD Manager, Liquent Insight Publisher, etc.)
  • Expertise in MS Office applications, particularly formatting in MS Word
  • Ability to support use of document management systems and regulatory information management systems (e.g., Veeva Vault RIM)
  • Strong written and verbal communication skills
  • Strong organizational skills and attention to detail
  • Ability to adapt to changing priorities and timelines

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.


PI115262683

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>The Regulatory Operations Specialist/Sr Specialist is responsible for document-level publishing, submission level publishing in eCTD and other electronic formats, and support for ACADIA Regulatory Affairs systems. Under moderate supervision, the Regulatory Operations Specialist/Sr Specialist works with team members in Regulatory Affairs and other functions to deliver timely and technically valid electronic submissions. As needed, the Regulatory Operations Specialist/Sr. Specialist will participate in systems projects by supporting requirements definition, testing, data migration, and training.</p> <p> <strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Performs document-level publishing tasks including formatting, bookmarking, and QC (publishing-focused)</li> <li>Performs report-level publishing for complex documents including nonclinical reports, clinical study reports, PADERs, and DSURs</li> <li>Independently publishes routine submissions to ACADIA INDs and NDAs including but not limited to: general correspondence, protocol amendments, information amendments, and annual reports/PADERs/DSURs</li> <li>Works with senior regulatory operations team members, submission managers, and other team members to publish and coordinate QC of large submissions including but not limited to: original NDAs and supplements, original INDs and major information amendments, responses to health authority questions</li> <li>On an as-needed basis provides training and support to users within Regulatory Affairs and other ACADIA functions on systems including Veeva Vault RIM and IQVIA RIM Smart</li> <li>On an as-needed basis develops and maintains work instructions related to document/report/submission publishing and QC and archiving</li> <li>Works with team members to support system implementation and upgrades. Specific tasks may include assistance in defining requirements, development and execution of test scripts, and migration of data and documents</li> <li>As needed, review health authority guidance to determine impact to ACADIA Regulatory Operations processes</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>Bachelors degree in a scientific discipline, information technology, or business administration preferred</li> <li>Minimum of 5 to 8 years experience in Regulatory Affairs or related function</li> <li>With moderate supervision, demonstrated ability to prioritize work, escalating concerns to management as needed</li> <li>Understanding of eCTD and electronic publishing concepts (e.g., lifecycle management, metadata, bookmarking and hyperlinking)</li> <li>Prior experience with eCTD/electronic publishing systems (e.g., IQVIA RIM Smart, Extedo eCTD Manager, Liquent Insight Publisher, etc.)</li> <li>Expertise in MS Office applications, particularly formatting in MS Word</li> <li>Ability to support use of document management systems and regulatory information management systems (e.g., Veeva Vault RIM)</li> <li>Strong written and verbal communication skills</li> <li>Strong organizational skills and attention to detail</li> <li>Ability to adapt to changing priorities and timelines</li> </ul> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/DoMVxlhVRBQqTYwysqlaM"> <p>PI115262683</p>

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Posted: 2019-11-07 Expires: 2019-12-08

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Senior Regulatory Operations Specialist

ACADIA Pharmaceuticals
San Diego, CA 92101

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