ALIM Proofreader
- Employer
- Pfizer
- Location
- Remote, Alaska
- Salary
- Competitive
- Posted
- May 25 2022
- Ref
- 4853991
- Discipline
- Other, Legal/Regulatory Affairs
- Position Type
- Full Time
- Organization Type
- Pharma
ALIM PROOFREADER
Supports workload in one or more ALIM regional leads and will be responsible for verification of information in final printed secondary packaging component artwork against Editor's copy documents for accuracy and consistency. Involves technical review of secondary packaging components across Pfizer portfolio and across multiple markets (languages) worldwide according to specifications and trade dress requirements as outlined in Pfizer SOPs.
Liaises with Worldwide Safety & Regulatory (WSR) Pfizer Country Offices (PCOs), Global Labeling Management (GLM), the geographically distributed artwork centers within Pfizer Global Supply (PGS). Provide document verification proofing of packaging and labeling artwork versus Editor's Copies (EC's) to assure compliance with required local country (and/or regional) format and style guidelines. Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines. Initiate discussions with ALIM Market Coordinators, WSR PCOs or PGS artwork centers/plants when inconsistencies are discovered. Annotate packaging and labeling artwork using digital tools. Use appropriate judgment and approve or reject packaging and labeling artwork. Provide clear explanation to PGM artwork center for accurate re-creation of artwork when needed. Monitor individual document verification proofing workload and ensure ALIM meets agreed upon Pfizer Artwork Request (PAR) timelines. Provide editorial comments for regulatory documents prior to creation of artwork by PGM sites to GLMs and/or WRS if requested. Escalate issues and initiate discussions with ALIM Market Coordinators (or GLM Hub Labeling Managers, WRS PCOs etc.) to drive consistency within and across labeling documents.
Qualifications
Bachelor's degree plus 2 years experience * in proofing pharmaceutical labeling, packaging components or medical/scientific documents. (4 plus years experience in pharmaceutical proofreading may be considered in lieu of degree.) Strong editing/proofreading skills, including broad vocabulary and knowledge of medical/scientific terminology. Attention to detail and ability to focus attention for long periods of time. Robust text comprehension and ability to identify and mark errors in typography, spelling, word usage, style, punctuation and grammar. Ability to apply these skills across multiple languages, especially non-native language is highly desirable. Ability to use mechanized and electronic proofreading tools such as vision systems and comparators. Excellent interpersonal, organization and communication skills. Individual must be flexible and capable of prioritizing projects, meeting deadlines and working well under pressure.
PHYSICAL/MENTAL REQUIREMENTS
Must be able to work effectively with frequent reading, which may cause eye strain. 20/20 color vision (corrected) is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional overtime may be required.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.
Regulatory Affairs
Supports workload in one or more ALIM regional leads and will be responsible for verification of information in final printed secondary packaging component artwork against Editor's copy documents for accuracy and consistency. Involves technical review of secondary packaging components across Pfizer portfolio and across multiple markets (languages) worldwide according to specifications and trade dress requirements as outlined in Pfizer SOPs.
Liaises with Worldwide Safety & Regulatory (WSR) Pfizer Country Offices (PCOs), Global Labeling Management (GLM), the geographically distributed artwork centers within Pfizer Global Supply (PGS). Provide document verification proofing of packaging and labeling artwork versus Editor's Copies (EC's) to assure compliance with required local country (and/or regional) format and style guidelines. Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines. Initiate discussions with ALIM Market Coordinators, WSR PCOs or PGS artwork centers/plants when inconsistencies are discovered. Annotate packaging and labeling artwork using digital tools. Use appropriate judgment and approve or reject packaging and labeling artwork. Provide clear explanation to PGM artwork center for accurate re-creation of artwork when needed. Monitor individual document verification proofing workload and ensure ALIM meets agreed upon Pfizer Artwork Request (PAR) timelines. Provide editorial comments for regulatory documents prior to creation of artwork by PGM sites to GLMs and/or WRS if requested. Escalate issues and initiate discussions with ALIM Market Coordinators (or GLM Hub Labeling Managers, WRS PCOs etc.) to drive consistency within and across labeling documents.
Qualifications
Bachelor's degree plus 2 years experience * in proofing pharmaceutical labeling, packaging components or medical/scientific documents. (4 plus years experience in pharmaceutical proofreading may be considered in lieu of degree.) Strong editing/proofreading skills, including broad vocabulary and knowledge of medical/scientific terminology. Attention to detail and ability to focus attention for long periods of time. Robust text comprehension and ability to identify and mark errors in typography, spelling, word usage, style, punctuation and grammar. Ability to apply these skills across multiple languages, especially non-native language is highly desirable. Ability to use mechanized and electronic proofreading tools such as vision systems and comparators. Excellent interpersonal, organization and communication skills. Individual must be flexible and capable of prioritizing projects, meeting deadlines and working well under pressure.
PHYSICAL/MENTAL REQUIREMENTS
Must be able to work effectively with frequent reading, which may cause eye strain. 20/20 color vision (corrected) is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional overtime may be required.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.
Regulatory Affairs