Associate I

3 weeks ago


Chennai Tamil Nadu, India Pfizer Full time

ROLE SUMMARY

ROLE RESPONSIBILITIES
- Auditing (verifying) of data and information against source documents and data systems for completeness and accuracy. Perform data verification of Biologics License Applications, Investigational New Drug Applications and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures. Perform data verification of other scientific / technical documentation per department practices.
- Document editing and formatting to meet corporate and regulatory submission format requirements.
- Collaborate with scientists and engineers in support of technical report and regulatory document authoring, editing, and auditing. Individual will consult with scientists/engineers and project leads for scope of work but is expected to work independently most of the time.
- Working with global scientists and engineers, may perform technical authoring of internal memos and reports and specific CMC sections of regulatory documents using templates and technical reports.
- Identify gaps in regulatory documentation readiness and work with team members to resolve (e.g. definition of source documents, creation of report templates, etc.)
- Serve as a local point of contact /SME for sharing lessons learned/best practices for systems and work practices around scientific documentation (e.g. GDMS, PDM, DV).
- Contribute to tracking regulatory documentation progression within teams and other scientific documentation metrics.

Preferred Education:

- Bachelors of Science or Engineering in Biological, Chemical or Pharmaceutical scientific or engineering discipline with 2 years of experience in technical/medical or scientific writing (or)
- Master of Science or Engineering in Biological, Chemical or Pharmaceutical scientific or engineering discipline

Preferred Experience:

- 2+ years of work experience in a technical/medical/scientific writing or knowledge management role, or in a scientific/engineering role with emphasis on writing and documentation, ideal if in development of biological therapeutics and/or vaccines within the biopharmaceutical industry.
- Demonstrates rigorous attention to detail.
- Excellent written English scientific writing skills (biological/ chemical/ pharmaceutical technical writing skills preferred)
- Excellent written and oral communication skills, with experience in scientific writing preferred.
- Ability to prioritize and manage multiple activities and objectives simultaneously. Highly developed organizational skills.
- Ability to work independently on individual goals and contribute collaboratively to team goals. Familiarity with regulatory/ICH guidelines highly desirable.
- Experience working in a regulated industry is preferred. Familiarity with GxP (especially GMPs) preferred.
- Familiarity with Documentum based knowledge management and document repository systems (electronic document management systems) is preferred.
- Familiarity with electronic lab notebook and Laboratory Information Management Systems (LIMS) systems and concepts is desirable.

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

LI-PFE


  • Associate Level I

    4 weeks ago


    Chennai, India BNP Paribas Full time

    ASSOCIATE LEVEL I (JOB NUMBER: BUS000881) **Direct Responsibilities** Develop & maintain all BCP related documentation Propose functional and technical recovery solutions, to be validated by the management of the entity and/or BCP Committee Ensure that members of staff are adequately trained for BCP. Roll out an awareness program Be an active member of...


  • Chennai, India VARITE INDIA PRIVATE LIMITED Full time

    Description: Location: Chennai/Hyderabad Exp: Fresher to 1 Year Shift:7 AM-5 PM IST /10 AM-7 PM IST /5 PM-2 AM IST ( Rotational shifts) Role:Data Entry Associate I - Excellent written and verbal communication with no MTI - Interview process 1st round might be an assessment and 2nd round might be in person interview (F2F) which is yet to get confirmation...

  • Associate Level I

    7 days ago


    Chennai, India BNP Paribas Full time

    ASSOCIATE LEVEL I (JOB NUMBER: MFS000497) **Direct Responsibilities** - Keep up and manage every operational aspects linked to the activity of US AGL team. (Collateral booking and returns) - Ensure settlement of collateral trades. Monitor all the collateral trades are settled on time in adherence to the settlement cycle. - Understanding the importance of...

  • Procurement Associate

    4 weeks ago


    Chennai, Tamil Nadu, India IFC Systems Corporation Full time

    **Procurement Associate (Category Associate)** **Job #**: - req27101**Organization**: - World Bank**Sector**: - Procurement**Grade**: - GD**Term Duration**: - 3 years 0 months**Recruitment Type**: - Local Recruitment**Location**: - Chennai,India**Required Language(s)**: - English**Preferred Language(s)**: **Closing Date**: - 4/29/2024 (MM/DD/YYYY)...


  • Coimbatore, Tamil Nadu, India I Digimeta Technology Pvt Ltd Full time

    **Job Title: Process Associate (Trainee)** **Required Skill**: - Knowledge in MS Office. - Typing speed and accuracy - Excellent knowledge of correct spelling, grammar and punctuation - Attention to detail - Confidentiality **Job Types**: Full-time, Permanent, Fresher **Salary**: From ₹7,500.00 per month **Benefits**: - Health insurance - Provident...

  • Payroll Associate

    4 weeks ago


    Chennai, Tamil Nadu, India Equiniti Full time

    Management Level I As attached

  • Device Associate I

    4 weeks ago


    Chennai, Tamil Nadu, India ADCI - Tamil Nadu Full time

    Knowledge of QA methodology and tools - A graduate in any field of study. To follow SOPs and execute tasks assigned on a daily basis. - Execute test plans & test cases, and reporting results in a timely, clear, and concise manner. - Meets daily productivity & quality targets. Is able to execute tasks on a daily basis with highest standard of quality w.r.t...

  • Procurement Associate

    4 weeks ago


    Chennai, Tamil Nadu, India World Bank Group Full time

    **Job #**: - req27101**Organization**: - World Bank**Sector**: - Procurement**Grade**: - GD**Term Duration**: - 3 years 0 months**Recruitment Type**: - Local Recruitment**Location**: - Chennai,India**Required Language(s)**: - English**Preferred Language(s)**: **Closing Date**: - 4/29/2024 (MM/DD/YYYY) at 11:59pm UTC**Description** **Unit...


  • Chennai, India Guidehouse Full time

    Job Family:EBO Accounts Receivable (India), EBO General (India)Travel Required:NoneClearance Required:NoneWhat You Will Do: Plans, monitors, direct and evaluate Associates production. Ensures that schedules are met and communicates with VP, and Associates Operations if situations occur that hinder meeting deadlines.   If system issues or other emergencies...

  • Procurement Associate

    4 weeks ago


    Chennai, Tamil Nadu, India IFC Systems Corporation Full time

    **Procurement Associate** **Job #**: - req26360**Organization**: - World Bank**Sector**: - Procurement**Grade**: - GD**Term Duration**: - 3 years 0 months**Recruitment Type**: - Local Recruitment**Location**: - Chennai,India**Required Language(s)**: - English**Preferred Language(s)**: - English**Closing Date**: - 3/8/2024 (MM/DD/YYYY) at 11:59pm...


  • Chennai, Tamil Nadu, India ADCI MAA 15 SEZ Full time

    Bachelor's degree The Kindle Ingestion and Expansion (KIX) team enables independent authors, content creators and publishers to publish their content as eBooks for distribution to the Kindle Store, Kindle Unlimited and the Kindle Owners’ Lending Library; as well as in print formats for sale on Amazon’s global marketplaces, bookstores and other online...


  • Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    Corporate Actions - IC1Responsible for mandatory and voluntary corporate actions custody functions for all organizational accounts. Receives guidance from more experienced staff. With guidance from more senior staff, responsible for processing basic mandatory and voluntary corporate action events (including the daily interpretation, monitoring, scrubbing and...


  • Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Client Processing - IC1Performs routine and non-routine client service and transactional support functions. Interacts with other organizational units/teams to ensure timely delivery of service, or resolution of issues. Processes account related transactions per scheduled events/client authenticated direction. Following established procedures,...


  • Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview With direct guidance, assists with risk management efforts for the assigned credit risk focus, such as Credit Analysis & Approval/Portfolio Management, Operational Credit Risk, Country Risk or Credit Administration. Helps with the development of documentation and reporting. Supports each team's adherence to the risk management strategy of the...

  • Associate - Gst

    7 days ago


    T Nagar, Chennai, Tamil Nadu, India Traecit Business Consultants Full time

    **Job description** Expert Point is looking for Associate in GST Team who can also work independently and to manage team with ownership and has good knowledge on filing the GST returns. **Job Responsibilities and Requirements**: a) Making all nature of compliances under the GST law for clients i.e. GSTR-1, GSTR-3B, GST Annual Return, GSTR 6, GST ITC-04...


  • Chennai, India Illumine-i Full time

    The Big PictureThe Electrical Engineer - Utility scale projects will own and drive the end-to-end designs for utility scale solar/BESS projects (20MW+), while also collaborating closely with cross functional teams to ensure on time delivery of high quality, fully compliant and comprehensive project solutions.What you can expect as Electrical Engineer –...

  • Procurement Associate

    4 weeks ago


    Chennai, Tamil Nadu, India World Bank Group Full time

    **Job #**: - req26360**Organization**: - World Bank**Sector**: - Procurement**Grade**: - GD**Term Duration**: - 3 years 0 months**Recruitment Type**: - Local Recruitment**Location**: - Chennai,India**Required Language(s)**: - English**Preferred Language(s)**: - English**Closing Date**: - 3/8/2024 (MM/DD/YYYY) at 11:59pm UTC**Description** **Unit...


  • Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    Provides advanced support for the completion of accounting activities for multiple legal entities, lines of business, countries, regions or accounting processes. Supports complex research and analyses related to financial performance and critical financial accounting issues.Coordinates the collection of data and other information required for the completion...


  • Chennai, India BNY Mellon Full time

    Vice President, Quality Assurance and Testing I 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...

  • Rapd Associate I

    4 weeks ago


    Chennai, India Pfizer Full time

    Contribute to the completion of project milestones and organize own work to meet project task deadlines. - Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. - Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics...