Associate I

6 months 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, Billing Representative I

    4 weeks ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Billing Representative I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Client Processing I

    6 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Client Processing 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 “bank of...

  • Associate, Reconciliation Representative I

    1 month ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Reconciliation Representative I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to...

  • Associate, Credit Risk I

    3 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Credit Services I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Corporate Actions I

    6 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate I, Corporate Actions 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, Client Processing I

    3 weeks ago

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

    **Associate, Client Processing I** At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions...

  • Associate, Corporate Actions I

    3 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Corporate actions I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Fund Administration I

    1 week ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Fund Administration I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Fund Administration I

    1 week ago

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

    Associate, Fund Administration I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions...

  • Associate, Billing Representative I

    2 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Billing Representative I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Position of Project Associate-i

    1 month ago

    Madhavaram, Chennai, Tamil Nadu, India Tamil Nadu Veterinary and Animal Sciences University Full time

    **TAMIL NADU VETERINARY AND** **ANIMAL SCIENCES UNIVERSITY** Veterinary College and Research Institute Namakkal - 637 002, Tamil Nadu Notification Number: 459 / ANN / SFS-FFT/VCRI / NKL / 2024 Date: 25.10.2024. **WALK IN INTERVIEW FOR THE POSITION OF PROJECT ASSOCIATE-I** A walk-in interview for the position of **Project Associate - I** (One Post) under...

  • Associate, Corporate Actions I

    4 weeks ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Corporate Actions I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Middle Office I

    4 weeks ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Middle Office I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions...

  • Associate, Payroll Administration I

    6 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Payroll Administration I-APAC Payroll 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...

  • Associate, Corporate Actions I

    1 week ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Corporate Action I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Billing Representative I

    3 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Billing Representative I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...

  • Associate, Middle Office I

    6 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview ASSOCIATE, MIDDLE OFFICE I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions...

  • Associate, Middle Office I

    6 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Middle Office I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions...

  • Associate, Middle Office I

    4 days ago

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

    ASSOCIATE, MIDDLE OFFICE I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions with...

  • Associate, Middle Office I

    4 days ago

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

    **Associate, Middle Office I** At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions with...