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Medical Writing QC Reviewer

Pfizer


Location:
Collegeville, PA
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1616475
Pfizer
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Job Details

Job Title Medical Writing QC Reviewer

JobID 1616475

Location: Collegeville, PA

Description The Medical Writing Quality Control (QC) Reviewer is a member of the Clinical Communications team within the Medical Writing department. The role manages and conducts QC activities to support delivery of accurate, compliant, and submission-ready documents prepared by authors in Medical Writing and clinical groups. Documents include (but are not limited to) protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, and regulatory responses.



Responsibilities



+ Independently perform QC review and manage QC projects in accordance with agreed upon timelines.

+ Verify accuracy of document content using source documents including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings.

+ Verify internal consistency within a document and across related documents

+ Verify uniformity and compliance of documents with internal and external standards (e.g., document templates, company style guide, publishing requirements).

+ Record QC findings and identify appropriate corrections to address findings.

+ Collaborate with document authors and other team members (as needed) to resolve QC findings.

+ Train colleagues on QC standards and processes as needed.



Qualifications



+ At a minimum, a Bachelor's degree or equivalent, preferably in a life science discipline. Advanced degree preferred.

+ At least 3+ years of experience in document QC and/or medical writing.

+ Solid understanding of medical terminology and clinical trials. Familiarity with clinical regulatory documentation desirable.

+ Critical attention to detail with ability to review documents against source files.

+ Strong organizational skills and ability to prioritize multiple projects and meet deadlines.

+ High degree of fluency in written and spoken English.

+ Excellent communication and interpersonal skills. Experience working within crossfunctional teams is desirable.

+ Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel).



**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: 9**

+ Additional Location Information: Any US Pfizer site or can be remote based.

+ Eligible for Employee Referral Bonus



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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