US Publishing Manager

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

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 utilization of global tools

How You Will Achieve It

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 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 limited effect on projects.  Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.  Exercises judgment to complete assigned tasks and has significant reliance on supervisor  Works in a structured environment under 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

Delivering project specific Pfizer paper and electronic submissions. Including co-ordination 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 local level.  Work with the Team Managers to effectively forecast and manage project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.  Adhere to the appropriate use of technical tools, through 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.  Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.  Engages leaders, business suppliers and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.  Leads the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.  Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department.  Provides guidance to and leads moderately complex submission and process improvement projects, making decisions independently.  Considered a technical resource within the group.  Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the group toward its goals.

Qualifications

Must-Have

• Bachelor's Degree plus 5 years experience
• Demonstrated experience in regulatory affairs, research and development or quality assurance/compliance
• Demonstrated experience in the pharmaceutical industry or relevant medical device experience as needed for the position
• Experience working directly with regulatory agencies
• Strong knowledge of the drug development process, regulatory affairs, CTA and submissions management
• Sound knowledge of applicable portions of agency guidance documents and regulations
• Exercises good judgment within company policy and health authority regulations with good negotiation skills
• Excellent written and interpersonal communication skills

Nice-to-Have

• Master's degree plus 3 years experience
• Relevant pharmaceutical experience
• Experience with lifecycle management of approved applications
• Functional/Technical Skills - has the functional and technical knowledge and skills to do the job at a high level of accomplishment  Acts Decisively - makes 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 and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably
• Proven experience managing or delivering through others in a matrix environment.  Demonstrated coordination of activities in a highly regulated environment.  Formal training in technical tools.  Strong knowledge of drug development process.  Demonstration of experience working in a customer service environment.  Relevant experience in electronic submissions builds within the Pharmaceutical Industry.  Experience of successfully mentoring others.
• Demonstrate an understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regulatory dossiers.  In depth knowledge of regulatory guidance and practices pertaining to technological aspects of submission management  Ability to work on multiple highly complex projects simultaneously.  Strong knowledge of the drug development process, regulatory affairs, and submissions management.  In depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation. Ability to operate seamlessly and influence/mentor direct and indirect reports, as well as across organizations

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

As needed, individuals may be asked to work non-standard work hours to achieve major and critical submission deadlines.

Other Job Details:

Last Date to Apply for Job:10/27/2021
Additional Location Information:USA - PA - Collegeville; United States - Illinois - Lake Forest; United States - North Carolina - Clayton
NO Relocation Package
Eligible for Employee Referral Bonus

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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.

Regulatory Affairs

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