Pfizer Training and Process Documentation Lead, Associate Director in New York City, New York

Manages training and process documentation across the Chemistry, Manufacturing and Controls (CMC) organization. Ensures alignment of all training materials and process documentation with approved requirements. Supports development of new process documentation and training. Defines, implements and monitors training standards appropriate for CMC business processes requirements including curricula and assignments. Drives process documentation development to enable CMC understanding and compliance and collaborates across CMC to find process documentation and training solutions that both meets business needs and ensures conformance. This position requires prior CMC experience.

Responsibilities

As the training and process documentation lead, manage requirements for the CMC area including:

  • Manage deliverables (procedural documentation and training) according to endorsed plans and timelines across multi-functional teams.

  • Manage development of training and process documentation strategy

  • Proactively identify and manage impacts to CMC training and process documentation and resulting training requirements, ensuring alignment across business lines and roles as appropriate.

  • Lead cross-functional team to drive a consolidated CMC training approach that appropriately meets business and compliance needs.

  • Training POC for CMC supporting: LMS updates, curricula (JFC) management and training compliance monitoring/conformance. Ensure quality of CMC colleague and contractor Training Record Files, ensure alignment of training with CMC processes.

  • Develop, implement and monitor training metrics and performance measures, reporting and analysis to meet business needs, and regulatory requirements

  • Lead change and improvement initiatives for training and procedural documentation as identified by business or through metrics evaluation.

  • Ensure compliance to procedural documentation and training and education regulatory requirements and consistent implementation of best practices, standards, and training globally to support inspection readiness

  • Process Documentation Point of Contact for CMC supporting:

  • Management of CMC procedures

  • Operational support to CMC lines in the creation of new or changes to existing process documentation.

  • Responsible for CMC procedural alignment: ensuring conformance between and within CMC procedures.

  • Ensure process documentation is appropriately reviewed by and administered within CMC.

  • Responsible for communication of all training and process documentation information across CMC, including development, management, and support of learning forums (e.g., College of Knowledge).

  • Serve on cross-functional teams (including but not limited to WWPS Learning Team, internal project teams, etc.) to represent CMC needs and provide guidance on training and process requirements.

  • Mentor colleagues or peers and serve as a role model

Basic Qualifications

  • BS - 7 years in pharmaceutical industry with focus on Pharmaceutical Sciences, Conformance/Quality, and Regulatory CMC

  • MS - 5 years in pharmaceutical industry with focus on Pharmaceutical Sciences, Conformance/Quality, and Regulatory CMC

  • Ph.D./PharmD/ MD - 3 years in pharmaceutical industry with focus on Pharmaceutical Sciences, Conformance/Quality, and Regulatory CMC

  • Firm understanding of CMC change management and the regulatory process

  • Experience managing/authoring procedure content across a global organization

  • Demonstrated knowledge of training and education principles, instructional design as well as project management

  • Prior experience in monitoring adherence to compliance-based training programs.

  • Demonstrated ability to influence and negotiate effectively, working globally with organizations/teams/individuals

  • Demonstrated ability to manage multiple, highly complex projects concurrently.

  • Required Computer Experience:

  • Knowledge of LMS administration and processing.

  • Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint,), Adobe Acrobat, survey tools

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.