Medical Writing Quality Lead (Director)
Location:
Collegeville , Pennsylvania
Posted:
October 20, 2017
Reference:
473465328

The Medical Writing Quality Lead is a key member of the Clinical Communications team within the Medical Writing department. In a highly visible role, the incumbent will lead the quality function in Medical Writing and will be the primary point of contact for quality control (QC) activities for documents written by authors in Medical Writing and clinical groups. She/he will have responsibility for recruiting and developing staff as well as creating processes that support the implementation of a quality function in Medical Writing. They will also have responsibility for QC activities to support delivery of high-quality, compliant, and submission-ready documents including (but not limited to) protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, and regulatory responses. Representing Medical Writing in key cross functional work streams, they will lead improvements in compliance with internal/external standards, inspection readiness, and operational efficiency. Key responsibilities: Provide leadership and direction to the Medical Writing Quality group. Manage workload of group including Pfizer colleagues and external contractors. Ensure group is well qualified and trained to perform QC activities. Provide coaching to colleagues to support performance management and career development. Effectively interact within a matrix organization to forecast, manage, and prioritize QC activities to support portfolio goals in multiple therapeutic areas and business units. Work closely with authors in Medical Writing and clinical groups to coordinate QC reviews and ensure timely delivery of documents. Promote open communication regarding QC status and issue resolution. Work closely with Medical Writing management to develop document compliance objectives and operational delivery model. Lead implementation of organizational infrastructure with comprehensive and uniform QC processes and standards. Demonstrate subject matter expertise in QC specialty areas including data checking, clinical editing, and document submission readiness standards. Apply relevant experience in process improvement and change leadership. Develop QC processes, standards, and training to support compliance with evolving internal and external standards. Work closely with other functions to influence and implement strategies to improve operational efficiency and inspection readiness. Participate and/or lead business processes to support functional excellence, quality, and innovation. Qualifications: At minimum Bachelor degree or equivalent in a discipline pertinent to drug development. Advanced degree preferred. BS/BA +10 years, MS/MA +7 years of relevant experience in the pharmaceutical or biotech industry, including at least 2 years leading a quality function. Expertise in document QC specialty areas related to data checking, clinical editing, and document submission readiness. Experience with audits and/or inspections desirable. Experience in people management and talent development. Excellent interpersonal, communication, negotiation, and project management skills. Proven ability to establish and maintain professional and productive working relationships. Demonstrated record of implementing process improvements through change management. 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. Additional Offer Details: This job is Pfizer Exempt US Grade: 16 Additional Location Information: La Jolla, CA; New York, NY; Collegeville, PA; Groton, CT; San Francisco, CA; or any other US Pfizer site; can also be remote based Eligible for Employee Referral Bonus A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. 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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