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Global Publishing Head

Pfizer


Location:
Collegeville, PA 19426
Date:
12/27/2017
2017-12-272018-01-27
Pfizer
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Job Details

**ROLE SUMMARY**



To oversee and direct Pfizer's global portfolio of publishing activities within the Worldwide Safety and Regulatory- Worldwide Regulatory Operations (WSR-WRO) group. Ensures that Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations while working to tight, business-critical, deadlines within a highly regulated environment. Holds single point of accountability for overall management of global publishing standards and quality deliverables. Supports workload balancing in all geographical locations.







**ROLE RESPONSIBILITIES**







+ Own accountability for the Publishing execution of Pfizer's global submission portfolio (~40K per annum)



+ Direct and actively supervise US/UK Publishing teams and hold matrix oversight of up to 100 FTE/Vendor publishing resources globally.



+ Own accountability for publishing standards and training materials to serve U.S. / EU / LATAM / CA / AfMe / EME / Asia countries.



+ Oversee successful, compliant, on time delivery of all submission types for identified countries.



+ Interpret technical requirements for global electronic and paper based submissions globally



+ Own accountability for setting strategic direction of the Publishing discipline.



+ In partnership with Information Management, implement technologies (COTS, Robotics, AI) in support of submissions publishing to generate efficiencies and meet regulatory requirements.



+ Serve as a major source of innovative ideas seeking efficiencies, effectiveness and scalability whilst maintaining the submission portfolio



+ Collaborate with identified PPLS Vendor Oversight Lead to coordinate and manage vendors with regard to future volume planning and potential changes in vendor responsibilities to meet Pfizer business needs



+ Oversee business continuity planning, work load balancing and follow the sun capabilities.







**QUALIFICATIONS**







+ Master's or Undergraduate degree plus relevant experience



+ Leadership skills: Minimum of 5 years Supervisory, organizational and matrix leadership



+ Regulatory Operations Expertise: Minimum of 10 years demonstrated knowledge of Regulatory submissions, code, guidance, specifications, and eCTD technologies.



+ Communication Skills: Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.



+ Technology: Experience with publishing software, XML, Document Management, regulatory milestone reporting tools







Project Management experience: Minimum of 5 years, Mastery of processes, tools and techniques for planning and monitoring projects to established deadlines. Familiarity with pharmaceutical organizational structures, systems, and culture.







**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.







**Other Job Details:**







+ (Required except when open ended) **Last Date to Apply for Job: 1/12/18** Additional Location Information: Groton, CT Lake Forest, IL New York City and Sandwich, UK







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