Associate Ii
2 months ago
Job Description
JOB SUMMARY:
- Managing individual projects of benefit to therapeutic area teams within the group
- Support for use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
JOB SUMMARY:
- Author and Maintain Regulatory Product profile documents by updating as requested by strategist when key milestones occur. Including status of product indications supplement status per AG settlement
- Generate Pearl reports, WWRS reports etc, in support of Renewals, launches and health authority queries on need basis.
- Support registration of new products by Dossier QC, CCS QC, gap analysis, anticipated health authority query tracker and coordination between stake holders.
- Quality check of submission packages like NDA AR, PADER, PSUR, DSUR, CAR and PBRER.
- Author and maintain Global Regulatory Strategy Documents as requested by strategist.
- Support data analysis, data mining, report generation using various Pfizer internal systems like GDMS, Pearl, Label Central, CAL-ODW, Epalms etc.
- Support data remediation activities like Pearl Remediation etc as requested by cluster group.
- Support GDMS archivals, ROC creation using SCC support, GDMS folder creation etc., in support of archving agency correspondences in GDMS.
- Create, maintain and update internal trackers for cluster, product variation trackers etc as requested by strategist and cluster group
- Upload on going clinical study documents into Pfizer Trial Master file as requested by strategist.
- Provide targeted documentation searches in GDMS in support of responding to Health Authority queries and/or internal queries (such as AG settlement information search or searches to support medical information responses)
- Support for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product) by preparing label comparison documents
- Prepare label chronology document for Pfizer products as requested by Strategist
- Prepare draft meeting notes, archiving meeting minutes and action item lists for Labeling and Rapid Response Team (RRT) meetings as needed
- Education: Post Graduate in Pharmacy or Science. 2 to 6 years of experience preferred.
- Skills
- Required - excellent written, listening and verbal communication skills, ability to problem solve, technical aptitude ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with appropriate level of supervision, experience in customer service environment, aptitude in project management and logistics
- Preferred - knowledge of regulatory processes and documents, knowledge of therapeutic areas
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
-
Associate - Housekeeping
4 weeks ago
Tamil Nadu, India Sodexo India On-site Services Full timeAssociate - HK Unskilled **EXPERIENCE**: - 2 - 3 years **LOCATION**: - No. 77 ,SIPCOT INDUSTRIAL COMPLEX, PHASE II, KUMUDEPALLI, HOSUR, KRISHNAGIRI DIST, TN 635109 THORAPALLY TAMIL NADU 121001 **CONTACT**: - Lavanya.
-
Associate, Control II
4 days ago
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Control II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - %...
-
IT Support Associate Ii, IT Services
4 weeks ago
Chennai, India ADCI - Tamil Nadu Full timeBachelor’s degree or Diploma in any discipline. - Total 2+ years of experience in IT support domain includes asset management. - Hands on experience in Windows. - Should be capable to complete the task following the standard operating procedure. - Should have experience in understanding IT equipment’s, peripherals and IT Warehouse. - Should have...
-
Welder Ii
1 month ago
Coimbatore, Tamil Nadu, India CIRCOR Full time**Welder II** **ORGANIZATIONAL STRUCTURE** BUSINESS: Circor Refinery Valves LOCATION: Coimbatore, India DIRECT REPORTING: Supervisor FUNCTIONAL REPORTING: NA **POSITION DETAILS** **_ Position Summary_** **_Principal Activities_** - Analyses Work Orders and associated Engineering Drawings to determine need for supplies and sequence of operations...
-
Associate, Control II
4 days ago
Chennai, India BNY Mellon Full timeAssociate, Control IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - 97% of the...
-
Data Scientist Ii
4 weeks ago
Chennai, India Caterpillar Full time**Career Area**:Information Analytics**: JOB PURPOSE: Caterpillar uses quantitative methods such as business simulations, data mining, and advanced statistical techniques to solve problems. The Data Scientist II contributes to this mission by leveraging his or her quantitative analysis, data management, modeling and/or data visualization skills as an...
-
Associate, Compliance
5 days ago
chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Compliance & Control II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...
-
Associate, Fund/Client Accounting II
2 days ago
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Fund/Client Accounting II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank...
-
Associate, Data Management
4 days ago
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Data Management & Quantitative Analysis II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known...
-
Associate, Compliance
4 days ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Compliance & Control II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...
-
Associate - Housekeeping
4 weeks ago
Tamil Nadu, India Sodexo India On-site Services Full timeUnskilled **EXPERIENCE**: - 2 - 3 years **LOCATION**: - No. 77 ,SIPCOT INDUSTRIAL COMPLEX, PHASE II, KUMUDEPALLI, HOSUR, KRISHNAGIRI DIST, TN 635109 THORAPALLY TAMIL NADU 121001 **CONTACT**: - Lavanya.
-
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Regulatory Analysis and Reporting II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...
-
Associate, Business Technology Liaison II
4 days ago
Chennai, India BNY Mellon Full timeAssociate, Quality Engineer IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” -...
-
Plmds Associate Ii
4 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeSecurities Finance Investigations Associate, Client Processing II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or...
-
chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeSecurities Finance Investigations Associate, Client Processing II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or...
-
Associate, Data Management
4 days ago
Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Data Management & Quantitative Analysis IIBring your ideas. Make history.BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...
-
Associate, Fund/Client Accounting II
2 days ago
Chennai, India BNY Mellon Full timeAssociate, Fund/Client Accounting IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...
-
Associate, Fund/Client Accounting II
15 hours ago
chennai, India BNY Mellon Full timeAssociate, Fund/Client Accounting II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...
-
chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full timeAssociate, Regulatory Analysis and Reporting II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...
