Publishing Manager (contract) - #495696

Pfizer


Date: 10/14/2021 17:30 PM

City: Lake Forest, Illinois

Contract type: Contractor

Work schedule: Full Day

Publishing Manager

  • Work Environment: Remote
  • Prefer resource to be local to Collegeville, PA or Lake Forest, IL to connect with Pfizer teams
  • Possible weekend work at high volume designated time


Summary:


Members of this team hold responsibility for defining and upholding Pfizer publishing standards and practices to meet agency requirements globally. In addition, Specialists are required to execute against required dossier development build and publishing activities within Publishing and Product License Support (PPLS), ensuring that Pfizer delivers on all regulatory submission milestones and maintains compliance with applicable regulatory obligations. They must provide technical expertise to partnering business lines to drive excellence in the design, implementation, and delivery of regulatory submissions.


This role reports to the Publishing Team Manager, PPLS Sr Team Manager, PPLS Team Lead, or Publishing Team Lead and sits within a team working to tight, business-critical deadlines within a highly regulated environment. Primary accountability is for the designated region/areas of responsibility, with additional accountability to support other publishing locations through the utilization of global tools.


Responsibilities:

  • Contributes to the completion of project tasks and/or milestones
  • Organizes own work to meet project task deadlines
  • Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within the context of immediate Work Team
  • Has fundamental knowledge of the principles and concepts of the discipline
  • Applies technical skills to achieve assigned tasks
  • Contributes to the completion of routine Work Team related tasks
  • Uses established procedures and methodologies
  • Makes decisions that require choosing between limited options to resolve problems basic in their complexity
  • Has limited decision-making authority
  • Performs work in a structured environment under direction from supervisor
  • Decisions impact own work and have a limited effect on projects
  • Decisions have a limited effect on the delivery of scheduled work and may affect the allocation of existing resources
  • Exercises judgment to complete assigned tasks and has significant reliance on supervisor
  • Works in a structured environment under the direct supervision
  • Uses established procedures to perform assigned tasks
  • Asks for guidance from other colleagues
  • Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
  • Communicates straightforward information, asks questions, and checks for understanding
  • May use existing communication materials to explain information and persuade others in straightforward situations
  • Participates and contributes as a team member
  • Is responsible for certain team deliverables
  • Delivering project-specific Pfizer paper and electronic submissions. Including coordination and execution of publishing solutions that meet unique requirements of each submission, and management of product delivery to regulatory agencies.
  • Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier formats and publishing requirements as required
  • Liaison with Project Team representatives to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional markets
  • Definition, investigation, and implementation of regional and global process efficiencies for paper and electronic submission publishing, including the evaluation of current processes
  • Lead/participate on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions
  • Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at the local level
  • Work with the Team Managers to effectively forecast and manage project-specific resources utilizing flexible resourcing, and global load-sharing as a normal business practice
  • Adhere to the appropriate use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved
  • Define and implement standards and regional process efficiencies for submission publishing and project learning sessions to meet these standards
  • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
  • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites
  • Be a key expert and interface with the Publishing Vendor to ensure timely delivery, quality, and accuracy of work


Qualifications:

  • Bachelor's degree level
  • Minimum 2+ years of FDA Documentation & Compliance like 21 CFR Part 11 knowledge is required
  • Minimum 2+ years ECTD experience is required
  • Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards
  • Proven technical aptitude and fluency with publishing tools
  • Advanced Microsoft Office Suite skills
  • Proficient in the use of Publishing and Document Management
  • Minimum 2+ years of experience with Adobe Acrobat is preferred
  • Minimum 1+ years of project management experience is preferred
  • Minimum 1+ years of experience with Health Canada is preferred
  • Familiarity with pharmaceutical organizational structures, systems, and culture is preferred


Core Competencies:

  • Functional/Technical Skills – has the functional and technical knowledge and skills to do the job at a high level of accomplishment
  • Acts Decisively – make decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
  • Seizes Accountability –will stand up and be counted; doesn’t shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment
  • Change Agile – can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty
  • Peer Relationships- can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers
  • Influencing – Uses a range of effective communication styles and creates an inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably


Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

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