Associate I

2 days 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, Corporate Actions I

    7 days ago

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

    **Associate, Corporate Action I** At BNY, our culture allows us to run our company better and enables employees’ growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world’s investible assets. Every day, our teams harness cutting-edge AI and breakthrough...

  • Associate, Fund Administration I

    6 days 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...

  • Position of Project Associate-i

    2 days 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 I

    2 weeks ago

    Chennai, Tamil Nadu, India The Lincoln Electric Company Full time

    Associate I - Functional - Location**:Chennai** Employment Status**:Salary Full-Time** Req ID**:27217** - Job Responsibilities- Work with other members of Global SAP ERP teams based in Corporate IT, Europe IT, Mexico IT, South America IT and China IT to support Lincoln Electric (LE) subsidiaries with existing and newly implemented SAP deployments - Review,...

  • Associate, Fund Administration Representative I

    2 days ago

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

    Associate, Fund Administration 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, Middle Office I

    7 days ago

    Chennai, Tamil Nadu, India BNY 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...

  • Associate, Reconciliation Representative I

    1 week ago

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

    **Associate Reconciliation 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...

  • Quality Assurance Technician I, Vega Support

    2 weeks ago

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

    BE, BTech, Master of computer Applications (MCA), Bsc Computers, BCA, MSc Information Technology (IT) QAT I will primarily function in teams within QS that have opportunities to write and maintain test cases for different features. They exhibit technical capability to execute automated test scripts, develop utilities or tools to improve efficiency and...

  • Associate, Cash Processing/funds Transfer I

    6 days ago

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

    **Associate, Cash Processing/Funds Transfer 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, Accounting Representative I

    1 day ago

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

    Associate, Accounting 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 our...