Oracle Argus Projects Consultant job - Katalyst HealthCares & Life Sciences

Oracle Argus Projects Consultant - Job Description: Manages and Coordinates the qualification and deployment of Adverse Events Reporting Systems (Oracle Argus). Solid technical background and experience related to Argus Safety, Argus Insight, Analytics. BIP / OBIEE reporting. E2B. Oracle SQL and PL/SQL.
https://www.indeed.com/viewjob?t=oracle+argus+projects+consultant&jk=d81acab3e3e353ab&_ga=2.127832526.2136219104.1519593558-833183749.1502106191

Regulatory Affairs Associate katalyst HLS

Responsibilities: Compile/review IND and NDA documents in e-CTD format Submit regulatory documents to the US FDA Help review the regulatory strategy for the group Keep up to date with current FDA regulations
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Regulatory Publishing consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
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Regulatory consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10879984&SearchString=&StatesString=&jobseq=9&rowsperpage=30&divisions=&divisions2=

Regulatory submission consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10879966&SearchString=&StatesString=&jobseq=11&rowsperpage=30&divisions=&divisions2=

Regulatory affairs consultant Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements-
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10879937&SearchString=&StatesString=&jobseq=14&rowsperpage=30&divisions=&divisions2=

Regulatory Affairs Associate Katalyst HLS

Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10879925&SearchString=&StatesString=&jobseq=16&rowsperpage=30&divisions=&divisions2=