Agent/ Attorney Firm Name:Fragomen, Del Rey, Bernsen Loewy LLP
Agent/ Attorney Phone:2126888555
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:1400 Broadway
Agent/ Attorney Address Line 2:
Agent/ Attorney City:New York
Agent/ Attorney State/ Province:NEW YORK
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:10018
Agent/ Attorney Email:acharniauskaya@fragomen.com
Position Info
Prevailing Wage Track Number:P10020199720650
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level IV
Prevailing Wage:104874
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2020-12-17
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:150972
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:101 Orchard Ridge Drive
Worksite Address Line 2:
Worksite City :Gaithersburg
Worksite State:MARYLAND
Worksite Postal Code:20878
Job Title:Associate Director, R&D QA Audit
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:REGULATORY AFFAIRS, OR ONE OF THE MEDICAL SCIENCES (MEDICINE, PHARMACY, BIOLOGY, CHEMISTRY), OR REL
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :60
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Master's
Other Alternate Level of Education:
Acceptable Years of Experience:2
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:60
Accept Alternate Job Title:QA Auditor, Compliance Manager, or a related position in the pharmaceutical industry
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:MUST HAVE BACHELORS DEGREE OR FOREIGN EQUIVALENT IN REGULATORY AFFAIRS, OR ONE OF THE MEDICAL SCIENCES MEDICINE, PHARMACY, BIOLOGY, CHEMISTRY, OR A RELATED FIELD, PLUS FIVE 5 YEARS OF PROGRESSIVELY RESPONSIBLE EXPERIENCE IN THE POSITION OFFERED, AS A QA AUDITOR, COMPLIANCE MANAGER, OR A RELATED POSITION IN THE PHARMACEUTICAL INDUSTRY. MUST HAVE FIVE 5 YEARS OF PROGRESSIVELY RESPONSIBLE EXPERIENCE IN THE FIELD OF QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY PERFORMING ALL OF THE FOLLOWING DESIGNING, CONDUCTING, MANAGING AND PARTICIPATING IN REGIONAL AND GLOBAL GOOD CLINICAL PRACTICES GCP AND PHARMACOVIGILANCE PV AUDITS INCLUDING CLINICAL STUDY SITES, VENDORS, LABORATORIES, CROS, IRBS, ECS, INTERNAL SYSTEMS AND PROCEDURES, SUBMISSION DOCUMENTS OF CLINICAL AUDITS AND INSPECTIONS; MANAGING TOOLS TO TRACK, TREND, AND REPORT GCP AUDIT DATA; MONITORING ADHERENCE AND RESOLVING NONCOMPLIANCE WITH COMPANY POLICIES AND APPLICABLE REGULATIONS INCLUDING ICH, GCP, AND 21 CFR; DRAFTING REGULATIONS IN RELEVANT GXP AREAS, QUALITY STANDARDS, AND GUIDANCE AS WELL AS THE LATEST REGULATORY AUTHORITY AND INDUSTRY INTERPRETATION; PERFORMING ADHOC FOR CAUSE AUDITS TO IDENTIFY OR CONFIRM SUSPECTED NONCOMPLIANCE AND ASSIST WITH ROOT CAUSE IDENTIFICATION; PLANNING, SCHEDULING AND CONDUCTING PREAPPROVAL INSPECTION PAI READINESS ACTIVITIES; WRITING RESPONSES AND CAPAS FOR POST INSPECTION ACTIVITIES, COMMUNICATING RESULTS TO INTERNAL AND EXTERNAL CUSTOMERS; REVIEWING SOPS; PROVIDING RISK ASSESSMENT OF VENDORS, SITES AND STUDIES TO ENSURE PROPER SUPPORT OF ALL CLINICAL PROGRAMS; AND INTERFACING BETWEEN CLINICAL QA AND CLINICAL DEVELOPMENT, CLINICAL OPERATIONS, BIOSTATISTICS, PHARMACOVIGILANCE AND REGULATORY AFFAIRS TO ENSURE ALIGNMENT OF MEDICAL STRATEGY, STUDY DESIGN AND EXECUTION. ALTERNATIVELY, THE EMPLOYER WILL ACCEPT A MASTERS DEGREE OR FOREIGN EQUIVALENT IN A STATED FIELD OF STUDY PLUS TWO 2 YEARS OF EXPERIENCE, IN THE POSITION OFFERED, AS A QA AUDITOR, COMPLIANCE MANAGER OR A RELATED POSITION IN THE PHARMACEUTICAL INDUSTRY. ANY SUITABLE COMBINATION OF EDUCATION, TRAINING OR EXPERIENCE IS ACCEPTABLE.br br 25 NATIONAL AND INTERNATIONAL TRAVEL IS REQUIRED TO VARIOUS AND UNANTICIPATED COMPANY AND CLIENT SITES.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-03-08
Job Oder End Date:2021-04-11
Sunday Edition Newspaper:Y
First Newspaper Name:The Washington Post
First Advertisement Start Date:2021-03-14
Second Newspaper Name:The Washington Post
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-03-21
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-03-05
Employer Website to Date:2021-06-01
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-03-14
Job Search Website to Date:2021-03-21
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-03-17
Local Ethnic Newspaper to Date:2021-03-17
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:CHINA
Foreign Worker Birth Country:CHINA
Class of Admission :L-1
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:MEDICAL SCIENCE U.S. EQUIVALENT
Year of Compelted Education:1999
Foreign Worker Istitution of Eduation:BEIJING UNION UNIVERSITY
Foreign Worker Education Instution Address Line 1:NO. 27 DONGSISHITIAO
Foreign Worker Education Institution Address Line 2:DONG CHENG DISTRICT
Foreign Worker Education Institution City:BEIJING
Foreign Worker Educatution Institution State:
Foreign Worker Education Institution Country :CHINA
Foreign Worker Education Training Post Code:100007
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :N
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay for Education:N
Foreign Worker Currently Employed:Y
Employer Completed Application :N
Preparer Name:Hyla K Rosenberg
Preparer Title:Partner
Preparer Email :ACharniauskaya@fragomen.com
Employer Information Declaration Name:Adriana ECHEVERRI
