React JS Developer
Hyderabad, TG
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1397
22 AUG 2025
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View Details |
Role Overview We’re seeking a skilled React Developer to build dynamic, responsive, and scalable web applications. You’ll collaborate with cross-functional teams to translate UI/UX designs into high-quality code and ensure seamless user experiences across platforms. Key Responsibilities - Develop new user-facing features using React.js
- Build reusable components and front-end libraries
- Translate wireframes and designs into functional code
- Optimize components for performance across devices and browsers
- Integrate RESTful APIs and third-party services
- Implement state management using Redux, Context API, or similar
- Conduct code reviews and maintain documentation
- Collaborate with designers, backend developers, and QA teams
Required Skills & Qualifications - Strong proficiency in JavaScript (ES6+), HTML5, and CSS3
- Deep understanding of React.js and its core principles
- Experience with Redux, React Router, and modern build tools (Webpack, Babel, etc.)
- Familiarity with RESTful APIs and asynchronous programming
- Knowledge of testing frameworks (Jest, Enzyme)
- Version control experience (Git)
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Production Support Associate
Hyderabad, TG
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1403
22 AUG 2025
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View Details |
Job Summary:
We are seeking a proactive and detail-oriented Production
Support Associate to join our Client’s support team. The ideal candidate will
have hands-on experience with MongoDB and MS SQL, and will be responsible for
managing support tickets, performing backend data modifications, and ensuring
smooth operation of production systems.
Key Responsibilities:
- Monitor
and respond to production support tickets via ZenDesk and email.
- Investigate
and resolve issues raised by the sales team or application-generated
alerts.
- Perform
backend data updates and corrections in MongoDB and MS SQL databases.
- Collaborate
with the BA lead and development team to triage and escalate issues.
- Document
recurring issues and contribute to knowledge base articles.
- Support
ongoing feature development by ensuring data integrity and system
stability.
- Participate
in on-call rotations and provide timely updates on issue resolution.
Required Skills & Qualifications:
- 1–3
years of experience in a production support or database operations role.
- Proficiency
in MongoDB and Microsoft SQL Server.
- Strong
understanding of database structures, queries, and data manipulation.
- Familiarity
with ticketing systems like ZenDesk.
- Excellent
problem-solving and communication skills.
- Ability
to work independently and manage multiple priorities.
Preferred Qualifications:
- Experience
in healthcare or pharmacy-related applications.
- Familiarity
with backend application architecture and APIs.
- Knowledge
of scripting languages (e.g., Python, PowerShell) for automation.
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Power BI Developer
Hyderabad, TG
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1402
19 AUG 2025
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View Details |
As a Power BI developer, your primary role
will be to deliver business intelligence services, lead BI software
development, and present Power BI reports. You will transform raw data into
cohesive, valuable reports capturing meaningful business insights.
Roles and Responsibilities:
- Designing and developing Power BI reports and dashboards to
meet the business stakeholders’ needs.
- Gathering and understanding business requirements for data
visualization and analysis.
- Collaborating with data engineers and analysts to acquire,
clean, and transform data for reporting purposes.
- Knowledge of data warehousing, data gateway, and data
preparation projects
- Knowledge of Data Analysis Expressions (DAX) for creating
calculations.
- Exhibit a foundational understanding of database concepts such as
relational database architecture, multidimensional database design, and
more.
- Design data models that transform raw data into insightful
knowledge by understanding business requirements in the context of BI.
- Ensuring data security and compliance with best practices.
- Troubleshooting and resolving issues in Power BI reports.
- Providing training and support to end users on using Power BI.
- Keeping up-to-date with the latest Power BI features and trends.
Required Power BI developer
requirements, qualifications & skills:
- 3 to 5+ years of experience as a Power BI developer with an excellent
track record.
- Detailed
knowledge and understanding of database management systems, OLAP, and the
ETL (Extract, Transform, Load) framework.
- Expertise
in SQL queries, SSRS, and SQL Server Integration Services (SSIS)
- Strong understanding of data modeling and data visualization
concepts.
·
Working knowledge of how to automate,
deliver, and schedule BI dashboards and reports. Familiar with relational and
non-relational databases.
- Excellent communication and collaboration skills. Ability to
work independently and as part of a team.
- Adaptability to changing business requirements.
- Power BI certifications are a plus.
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Jr.Recruiter
Hyderabad, TG
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1401
14 AUG 2025
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View Details |
Reports To: Senior Recruiter / Talent Acquisition
Manager
Mode of Work: In-Office
Timing: 8 AM to 5PM US Central time (India night shift)
Job Summary:
We are looking for a motivated and detail-oriented Junior
US Recruiter to join our Talent Acquisition team. The ideal candidate will
assist in identifying hiring needs, sourcing candidates, and supporting the
overall recruitment process.
Key Responsibilities:
- Collaborate
with Talent Acquisition managers/Sr.Recruiter to understand staffing needs
and job specifications.
- Post
job openings on company career pages, job boards, and social media
platforms.
- Proactively
seeking and identifying potential candidates from various channels to
build a diverse and talented candidate pipeline.
- Assisting
senior recruiters in coordinating candidate interviews and managing
recruitment databases, ensuring a seamless interview process.
- Maintaining
regular communication with applicants, providing timely updates on their
application status
- Maintain
and update the applicant tracking system (ATS) and recruitment databases.
- Prepare
recruitment-related reports and documentation as needed.
Qualifications & Skills :
- Bachelor
degree
- Minimum
2 years of experience in end to end US recruitment
- Familiarity
with Job portals, ATS platforms and Professional social media platforms
- Familiarity
with US tax terms like C2C, W2, 1099 etc
- Familiarity
with US Visa status and work authorizations.
- Strong
communication and interpersonal skills.
- Ability
to multitask, stay organized, and work in a fast-paced environment.
- Proficiency
in Microsoft Office Suite (Word, Excel, Outlook).
- Enthusiasm
for learning and developing a career in talent acquisition.
What We Offer:
- Opportunities
for growth within the talent acquisition or broader HR field.
- A
supportive and collaborative team environment.
- Salary
and benefits as per Industry standard.
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Financial Analyst
Hyderabad, TG
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1400
13 AUG 2025
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View Details |
Seeking high-performing Financial Analysts with strong expertise in financial modeling, valuation methodologies, and strategic analysis. This role will be instrumental in driving key financial insights for evaluating investment opportunities, supporting M&A initiatives and critical financial decisions. The ideal candidate is intellectually curious, analytically rigorous, and thrives in a fast-paced, high-stakes environment. Key Responsibilities: - Build and maintain complex financial models to support strategic decision-making, scenario analysis, and investment cases.
- Perform comprehensive valuation analyses including DCF, precedent transactions, comparable company analysis, and scenario modeling.
- Provide financial insights and recommendations to support M&A, capital allocation, fundraising, and strategic planning efforts.
- Lead financial, operational and customer due diligence on investment opportunities, partnerships, and acquisitions.
- Help analyze KPIs, assess financial performance, and develop forecasts and long-term financial plans.
- Present findings and recommendations clearly and persuasively.
- Maintain up-to-date industry knowledge and competitive benchmarking to assess business performance and risk.
- Drive process improvements in financial planning, modeling accuracy, and analytics infrastructure.
- Bachelor’s degree in Finance, Economics, Accounting, or related field; MBA or CFA preferred.
- experience in investment banking, corporate finance, private equity, or strategic consulting.
- Expert-level proficiency in Excel-based modeling, including dynamic forecasting, return, waterfall and scenario analyses, and Monte Carlo simulations.
- understanding of GAAP/IFRS accounting, corporate valuation techniques, Q of E, and capital markets.
- Experience in M&A transactions, capital raises or corporate restructurings.
- business acumen with the ability to translate complex financial data into actionable insights.
- Ability to work independently in ambiguous situations and deliver under tight deadlines.
- Knowledge of key investment fundamentals: COI, investment terms, preferences, change of control provisions, NVCA templates.
- Knowledge and practice of AI systems and processes to advance modeling capabilities
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Financial Analyst
Cochin, KL
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1399
12 AUG 2025
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View Details |
Seeking high-performing Financial Analysts with strong expertise in financial modeling, valuation methodologies, and strategic analysis. This role will be instrumental in driving key financial insights for evaluating investment opportunities, supporting M&A initiatives and critical financial decisions. The ideal candidate is intellectually curious, analytically rigorous, and thrives in a fast-paced, high-stakes environment. - Build and maintain complex financial models to support strategic decision-making, scenario analysis, and investment cases.
- Perform comprehensive valuation analyses including DCF, precedent transactions, comparable company analysis, and scenario modeling.
- Provide financial insights and recommendations to support M&A, capital allocation, fundraising, and strategic planning efforts.
- Lead financial, operational and customer due diligence on investment opportunities, partnerships, and acquisitions.
- Help analyze KPIs, assess financial performance, and develop forecasts and long-term financial plans.
- Present findings and recommendations clearly and persuasively.
- Maintain up-to-date industry knowledge and competitive benchmarking to assess business performance and risk.
- Drive process improvements in financial planning, modeling accuracy, and analytics infrastructure.
- Bachelor’s degree in Finance, Economics, Accounting, or related field; MBA or CFA preferred.
- experience in investment banking, corporate finance, private equity, or strategic consulting.
- Expert-level proficiency in Excel-based modeling, including dynamic forecasting, return, waterfall and scenario analyses, and Monte Carlo simulations.
- understanding of GAAP/IFRS accounting, corporate valuation techniques, Q of E, and capital markets.
- Experience in M&A transactions, capital raises or corporate restructurings.
- business acumen with the ability to translate complex financial data into actionable insights.
- Ability to work independently in ambiguous situations and deliver under tight deadlines.
- Knowledge of key investment fundamentals: COI, investment terms, preferences, change of control provisions, NVCA templates.
- Knowledge and practice of AI systems and processes to advance modeling capabilities
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Financial Analyst
Cochin, KL
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1399
12 AUG 2025
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View Details |
Seeking high-performing Financial Analysts with strong expertise in financial modeling, valuation methodologies, and strategic analysis. This role will be instrumental in driving key financial insights for evaluating investment opportunities, supporting M&A initiatives and critical financial decisions. The ideal candidate is intellectually curious, analytically rigorous, and thrives in a fast-paced, high-stakes environment. - Build and maintain complex financial models to support strategic decision-making, scenario analysis, and investment cases.
- Perform comprehensive valuation analyses including DCF, precedent transactions, comparable company analysis, and scenario modeling.
- Provide financial insights and recommendations to support M&A, capital allocation, fundraising, and strategic planning efforts.
- Lead financial, operational and customer due diligence on investment opportunities, partnerships, and acquisitions.
- Help analyze KPIs, assess financial performance, and develop forecasts and long-term financial plans.
- Present findings and recommendations clearly and persuasively.
- Maintain up-to-date industry knowledge and competitive benchmarking to assess business performance and risk.
- Drive process improvements in financial planning, modeling accuracy, and analytics infrastructure.
- Bachelor’s degree in Finance, Economics, Accounting, or related field; MBA or CFA preferred.
- experience in investment banking, corporate finance, private equity, or strategic consulting.
- Expert-level proficiency in Excel-based modeling, including dynamic forecasting, return, waterfall and scenario analyses, and Monte Carlo simulations.
- understanding of GAAP/IFRS accounting, corporate valuation techniques, Q of E, and capital markets.
- Experience in M&A transactions, capital raises or corporate restructurings.
- business acumen with the ability to translate complex financial data into actionable insights.
- Ability to work independently in ambiguous situations and deliver under tight deadlines.
- Knowledge of key investment fundamentals: COI, investment terms, preferences, change of control provisions, NVCA templates.
- Knowledge and practice of AI systems and processes to advance modeling capabilities
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Financial Analyst
Cochin, KL
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1399
12 AUG 2025
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View Details |
Seeking high-performing Financial Analysts with strong expertise in financial modeling, valuation methodologies, and strategic analysis. This role will be instrumental in driving key financial insights for evaluating investment opportunities, supporting M&A initiatives and critical financial decisions. The ideal candidate is intellectually curious, analytically rigorous, and thrives in a fast-paced, high-stakes environment. - Build and maintain complex financial models to support strategic decision-making, scenario analysis, and investment cases.
- Perform comprehensive valuation analyses including DCF, precedent transactions, comparable company analysis, and scenario modeling.
- Provide financial insights and recommendations to support M&A, capital allocation, fundraising, and strategic planning efforts.
- Lead financial, operational and customer due diligence on investment opportunities, partnerships, and acquisitions.
- Help analyze KPIs, assess financial performance, and develop forecasts and long-term financial plans.
- Present findings and recommendations clearly and persuasively.
- Maintain up-to-date industry knowledge and competitive benchmarking to assess business performance and risk.
- Drive process improvements in financial planning, modeling accuracy, and analytics infrastructure.
- Bachelor’s degree in Finance, Economics, Accounting, or related field; MBA or CFA preferred.
- experience in investment banking, corporate finance, private equity, or strategic consulting.
- Expert-level proficiency in Excel-based modeling, including dynamic forecasting, return, waterfall and scenario analyses, and Monte Carlo simulations.
- understanding of GAAP/IFRS accounting, corporate valuation techniques, Q of E, and capital markets.
- Experience in M&A transactions, capital raises or corporate restructurings.
- business acumen with the ability to translate complex financial data into actionable insights.
- Ability to work independently in ambiguous situations and deliver under tight deadlines.
- Knowledge of key investment fundamentals: COI, investment terms, preferences, change of control provisions, NVCA templates.
- Knowledge and practice of AI systems and processes to advance modeling capabilities
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Financial Analyst
Cochin, KL
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1399
12 AUG 2025
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View Details |
Seeking high-performing Financial Analysts with strong expertise in financial modeling, valuation methodologies, and strategic analysis. This role will be instrumental in driving key financial insights for evaluating investment opportunities, supporting M&A initiatives and critical financial decisions. The ideal candidate is intellectually curious, analytically rigorous, and thrives in a fast-paced, high-stakes environment. - Build and maintain complex financial models to support strategic decision-making, scenario analysis, and investment cases.
- Perform comprehensive valuation analyses including DCF, precedent transactions, comparable company analysis, and scenario modeling.
- Provide financial insights and recommendations to support M&A, capital allocation, fundraising, and strategic planning efforts.
- Lead financial, operational and customer due diligence on investment opportunities, partnerships, and acquisitions.
- Help analyze KPIs, assess financial performance, and develop forecasts and long-term financial plans.
- Present findings and recommendations clearly and persuasively.
- Maintain up-to-date industry knowledge and competitive benchmarking to assess business performance and risk.
- Drive process improvements in financial planning, modeling accuracy, and analytics infrastructure.
- Bachelor’s degree in Finance, Economics, Accounting, or related field; MBA or CFA preferred.
- experience in investment banking, corporate finance, private equity, or strategic consulting.
- Expert-level proficiency in Excel-based modeling, including dynamic forecasting, return, waterfall and scenario analyses, and Monte Carlo simulations.
- understanding of GAAP/IFRS accounting, corporate valuation techniques, Q of E, and capital markets.
- Experience in M&A transactions, capital raises or corporate restructurings.
- business acumen with the ability to translate complex financial data into actionable insights.
- Ability to work independently in ambiguous situations and deliver under tight deadlines.
- Knowledge of key investment fundamentals: COI, investment terms, preferences, change of control provisions, NVCA templates.
- Knowledge and practice of AI systems and processes to advance modeling capabilities
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Pharmaceutical Regulatory Consultant ??? Lipid-Based Products
Rosemont, IL
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1398
04 AUG 2025
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View Details |
Job
Summary:
We are
seeking an experienced Regulatory Affairs Consultant with specialized knowledge
in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides
such as EPA/DHA omega-3 fatty acids. The consultant will provide regulatory
support and strategic guidance for drug, dietary supplement, or nutraceutical
products containing fish oil derivatives, ensuring compliance
with global regulatory standards including FDA (CDER & CFSAN). The
Regulatory Affairs Consultant will serve as an essential resource within the
organization, providing technical expertise and regulatory guidance for the
development, manufacturing, and commercialization of lipid-based pharmaceutical
products. Strong cross-functional collaboration and communication skills are
required to ensure alignment across teams, alongside a deep understanding of
regulatory pathways for these products.
Department: Regulatory Affairs
Reports To: Vice President
Key
Responsibilities:
·
Develop and implement regulatory strategies for
lipid-based products derived from fish oil triglycerides for US market
·
Prepare, review, and manage regulatory
submissions including, ANDAs, NDAs
·
GRAS notifications, NDIs (New Dietary
Ingredients), and supplement notifications
·
Provide CMC regulatory input, with a focus on: Source
and purity of omega-3 fatty acids (EPA, DHA), stability, oxidation control, and
impurity profiling (e.g., peroxide values, anisidine values), manufacturing
process validation and GMP compliance
·
Interpret and apply relevant regulatory
guidelines: FDA guidance on fish oil-based APIs and dietary supplements, Q1-Q2,
Q3 Characterization, FDA guidelines on lipid-based excipients
·
Support Labeling, Claims, and Advertising
Compliance, ensuring alignment with 21 CFR Part 101 and Part 201
·
EFSA and Codex Alimentarius regulations (for
international markets)
·
Address regulatory queries and deficiency
letters from agencies and coordinate prompt responses.
·
Collaborate with R&D, Quality,
Manufacturing, and Marketing teams to ensure regulatory alignment throughout
the product lifecycle. Offer technical expertise in development, testing, and
manufacturing processes, including compatibility testing, stability studies,
process validation, and cleaning validation.
·
Stay informed on emerging trends, regulations,
and technologies related to Lipid products to identify opportunities for
process improvements and streamline regulatory processes.
·
Prepare and submit applications for lipid
products to regulatory agencies, primarily the US FDA, ensuring timely and
accurate submissions.
·
Assess regulatory reporting requirements using
FDA regulations, guidance documents, and in-house policies for change control
documentation
·
Develop and maintain regulatory trackers and
databases to monitor submission timelines, track regulatory changes, and
communicate updates to relevant stakeholders.
·
Partner with Regulatory Affairs, Quality
Assurance, Marketing, and Product Development teams to compile required
information and ensure compliance for all new products, changes to existing
products, and post-market activities.
Qualifications:
·
Bachelor’s degree in Life Sciences, Regulatory
Affairs, Chemistry, Engineering or a related field. Advanced degrees or
certifications in Regulatory Affairs (e.g., RAC) are a plus.
·
Minimum of 3-5 years of experience in the regulatory
field within the pharmaceutical industry, including 3+ years working with
lipid-based APIs or formulations (specifically fish oil triglycerides, ethyl
esters, or re-esterified forms).
·
Strong understanding of the regulatory pathways
for both Rx and non-Rx lipid products (including 505(b)(2), ANDA, GRAS, NDI).
·
Familiarity with eCTD software, regulatory
databases, and GMP documentation.
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Automation and Manual Tester
Kochi
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1390
06 MAY 2025
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View Details |
We are seeking a skilled Automation and
Manual Tester with expertise in JMeter, Selenium tool, Cucumber
Framework, Browserstack and other testing tools to join our quality
assurance team. The ideal candidate should have experience in both manual and
automated testing methodologies, ensuring the delivery of high-quality software
applications.
Key Responsibilities:
- Perform manual testing to identify bugs, usability issues, and
performance gaps.
- Develop, maintain, and execute automated test scripts using
tools like Selenium, using BDD Cucumber, and other relevant frameworks.
- Conduct performance testing using JMeter to assess application
scalability and stability.
- Design and document test cases, test plans, and test scripts
based on business and functional requirements.
- Collaborate with developers, business analysts, and product
teams to understand system functionality and testing requirements.
- Identify, document, and track bugs and defects using defect
tracking tools like JIRA or similar.
- Perform regression testing to ensure system stability after
code changes.
- Execute API testing using tools like Postman or REST Assured.
- Participate in agile development cycles, including daily
standups and sprint planning meetings.
- Ensure compliance with testing standards and best practices.
Required Skills & Qualifications:
- Bachelor's degree in Computer Science, IT, or a related field.
- Proficiency in automation testing tools like Selenium
WebDriver, JMeter, TestNG, or Cucumber.
- Hands-on experience with JMeter for performance testing
and browser stack.
- Experience with scripting languages like Java, Python, or
JavaScript for test automation and software Version Control (Git).
- Familiarity with SQL queries for database testing.
- Knowledge of CI/CD pipelines and integration with tools
like Jenkins.
- Strong understanding of SDLC, STLC, and Agile methodologies.
- Experience with API testing using Postman or REST
Assured.
- Excellent problem-solving skills and attention to detail.
Preferred Qualifications:
- Experience with cloud-based testing environments (AWS,
Azure).
- Knowledge of security testing concepts.
- ISTQB certification (a plus).
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Junior Underwriter
Shelton, CT, 06484
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1388
15 APR 2025
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View Details |
- Work
directly with Regional Vice President to collect, review and analyze an
applicant to determine the liability / level of risk of insuring, coverage
needs and appropriate pricing
- Offer
management recommendations on whether or not to approve an application
- Follow
up with Brokers to obtain documentation and outstanding items
- Keep
detailed records / notes of policies underwritten and decisions made
- Assist
management in developing and maintaining a profitable book of business
- Assist
management in negotiating terms, conditions and pricing to ensure profitability
- Work
within a team-oriented environment to collaborate on risk and strategy
- Develop
a comprehensive understanding of coverage forms and endorsements
- Develop
a comprehensive understanding of carrier guidelines
- Confidently
make educated decisions on behalf of Client and their carriers
Personality
Skills:
·
Strong work ethic
·
Strong organizational skills
·
Strong analytical skills
·
Personability or willingness to speak with clients via phone
call.
·
Desire to learn and grow and hunger for career growth
·
Willingness to take on Ad Hoc projects
·
Willingness to travel locally when / if needed
·
Team player / team-oriented mentality
·
Sensible judgement and attention to detail
Technical Skills:
·
3-5 years if prior experience underwriting
Commercial General Liability and / or Excess Liability
·
Basic knowledge of insurance policies and ability to relate
policy provisions to loss exposure
·
College Degree Not Required (Highly Preferred)
·
Ability to be in the Shelton, CT office 2-3x a
week (Highly Preferred)
·
Institute designations not required, but advantageous
and preferred.
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Regulatory Affairs- Project Manager
Rosemont, IL
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1387
08 APR 2025
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View Details |
- ·
Manage
the smooth running of all internal and external meetings and operational
aspects of product development.
- ·
Manage
the progress of projects ensuring that internal project management and quality
systems are effectively used to deliver the required project goals.
- ·
Advise
management on improvements that could be made to internal systems to assist
with project delivery.
- ·
Liaise
effectively with internal functions involved with each project, including but
not limited to: Project Management, Formulation & Process Development,
Analytical Support, Client Services, Production, Quality, Materials Stores,
Distribution, and Regulatory Affairs.
- · Participate
in meetings, conferences and correspondence with clients as required in
performance of function.
- ·
Develop
an understanding of each project deliverable and the clients’ key
requirements.
- ·
Be aware of key project issues and the
impact they have on the overall project plan.
Work actively with the client and internal resources to address any
project issues that threaten project success.
- ·
For each project maintain current and
accurate project plans for the purposes of client and management information.
Manage each project to comply with the agreed timelines.
- ·
Data management: Compiling,
reviewing, and collating documentation and data to ensure compliance
- ·
Regulatory guidance: Providing
regulatory guidance, classifications, and strategies
- ·
Communication: Communicating with employees at
all levels within the organization
- ·
Monitor
and track regulatory submission timelines and communicate updates to relevant
stakeholders.
- ·
Stay
current with changes in regulations, guidelines, and industry best practices
related to pharmaceuticals.
Education: Bachelor’s degree in
Life Sciences, Regulatory Affairs, Chemistry, or a related field. Advanced
degrees or certifications in Regulatory Affairs (e.g., RAC) are a plus.
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Business Development Manager (B2B)
Schaumburg, IL, 60173
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1381
07 FEB 2025
|
View Details |
The ideal candidate will lead the business development initiatives that includes acquisition of new clients and expanding TRINITE footprint at existing clients enhancing business opportunities for the company. With a focus on results, they will possess strong communication skills and the ability to think critically when planning. Additionally, they will have a proven track record of successfully achieving sales targets and business development strategies.
Responsibilities
· Identify
potential clients and opportunities
· Build
and nurture new relationships to drive business growth and support company
expansion
· Foster,
maintain and expand existing business relationships
· Strategically plan
to ensure successful project outcomes
· Manage
Profit and loss at each contract and client level
· Manage
business stakeholder relationships
Qualifications
· Bachelor's
degree or equivalent
· 3
to 4 years of relevant business development experience in B2B
· Excellent
communication and interpersonal skills
· Demonstrated
expertise in developing and executing successful business
development strategies
· Result oriented
with a strong focus on goals
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Program Manager
Detroit, MI, 48201
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1380
07 FEB 2025
|
View Details |
Strong Insurance Background Experience Leading Transformations Proven Expertise Leading up to 10 teams spread across various timezones Preferable GW experience SAFe Experience Nice to Have Must Have Policy and Billing System Expertise Strong RAID Management Ability to identify and put risk mitigation strategies Executive Presence
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Regulatory Affairs Specialist
Rosemont, IL, 60018
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1366
14 OCT 2024
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View Details |
Job Summary: The Regulatory Affairs Specialist/Sr.
Specialist is responsible for managing and overseeing the development, and review
of regulatory documents / deliverables / packages to ensure compliance with FDA
requirements for the US market. This role involves working closely with
cross-functional teams to support submission, review and product launches while
maintaining ongoing compliance throughout the product lifecycle in alignment
with Long Grove style guidelines.
Department: Regulatory Affairs
Reports To:
Regulatory Affairs Manager / Director /Vice President
Key
Responsibilities:
·
Assist
with the preparation and timely submission of New Product Applications, Annual
Reports, Periodic Adverse Events Reports (PADERs), Promotional Materials (OPDP)
and other post-marketing requirements to appropriate regulatory agencies (Primarily
US FDA).
·
Assess
the appropriate regulatory reporting mechanism using FDA regulations, guidance
documents, and in-house policies upon review of Change Control Documentation.
·
Work
closely with Regulatory Affairs, Quality Assurance, Marketing, and Product
Development teams to gather information and ensure that all of regulatory
documentation for new products, changes to existing products, and post-market
activities are compliant.
·
Review
and provide guidance on product labeling, structured product labeling (SPL), promotional
materials, and other product documentation to ensure compliance with regulatory
requirements.
·
Development/maintenance
of Regulatory trackers and databases.
·
Monitor
and track regulatory submission timelines and communicate updates to relevant
stakeholders.
·
Stay
current with changes in regulations, guidelines, and industry best practices
related to pharmaceuticals. Interpret and apply regulatory requirements to
ensure product submissions are accurate and compliant along with monitoring Drugs@FDA
website to align with RLD updates.
Qualifications:
Education: Bachelor’s degree in Life Sciences,
Regulatory Affairs, Chemistry, or a related field. Advanced degrees or
certifications in Regulatory Affairs (e.g., RAC) are a plus.
Experience: Minimum of 3-5 years of experience in
regulatory field within the pharmaceutical, biotechnology, or medical device
industry. Current knowledge of FDA guidelines (CFR 21).
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Senior Underwriter
Shelton, CT
|
1362
01 OCT 2024
|
View Details |
We are hiring a fulltime Senior Underwriter for our direct client who can work directly with Brokers (“Clients”) and to collect, review and analyze an applicant to determine the liability / level of risk of insuring, coverage needs and appropriate pricing - This candidate will be responsible for their own client base and build their own book of business.
- Solicit new business from Brokers, negotiate terms, conditions and pricing to ensure profitability
- Offer management recommendations on whether or not to approve an application
- Keep detailed records / notes of policies underwritten and decisions made
- Review Binders, endorsements, inspections, and follow up with Brokers to obtain documentation and outstanding items when assistants are unable to obtain
- Develop a comprehensive understanding of all PGIA carrier coverage forms and endorsements
- Develop a comprehensive understanding of PGIA carrier guidelines
- Work within a team-oriented environment to collaborate on risk and strategy
- Assist management in developing and maintaining a profitable book of business
- Confidently make educated decisions on behalf of PGIA and our carriers
Personality Skills: · Strong work ethic · Strong organizational skills · Strong analytical skills · Personability or willingness to speak with clients via phone call and / or in person. · Desire to learn and grow and hunger for career growth – embrace an entrepreneurial culture. · Willingness to take on Ad Hoc projects · Willingness to travel when / if needed · Team player / team-oriented mentality · Sensible judgement and attention to detail Technical Skills: · 5+ years of prior experience underwriting Commercial General Liability and / or Excess Liability · Comprehensive understanding of insurance policies and ability to relate policy provisions to loss exposure · College Degree Not Required (Highly Preferred) · Ability to be in the Shelton, CT office 1-2x a week (Highly Preferred) · Institute designations not required, but advantageous and preferred.
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