Agent/ Attorney Address Line 1:135 S LaSalle Street
Agent/ Attorney Address Line 2:Ste. 3425
Agent/ Attorney City:Chicago
Agent/ Attorney State/ Province:ILLINOIS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:60603
Agent/ Attorney Email:jhoskin@zulkiepartners.com
Position Info
Prevailing Wage Track Number:P10021034051206
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level III
Prevailing Wage:85966
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-06-17
Prevailing Wage Expiration Date :2021-09-15
Wage Offer From:101500
Wage Offer To:195800
Wage Offer Unit of Pay:Year
Workstie Address Line 1:650 E. Kendall Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2142
Job Title:US & International Regulatory Strategist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:PHARMACY OR RELATED FIELD
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:12
Accept Alternate Job Title:Doc Control Coordinator or rltd pstn
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:REQUIRED SKILLS PERFORM DOCUMENT CONTROL ACTIVITIES INCLUDING ISSUANCE, DISTRIBUTION, TRACKING, MONITORING, REVIEW AND ARCHIVAL OF SOPS, WORK INSTRUCTIONS, QUALITY MANUALS, TECHNICAL FILES, MASTER SPECIFICATIONS, TEST METHODS, STUDY PROTOCOLS AND REPORTS; ENSURE THAT DOCUMENT MANAGEMENT STRATEGIES AND REGULATORY REQUIREMENTS ARE UPHELD WITH RESPECT TO INTERNAL AND EXTERNAL QUALITY AND REGULATORY STANDARDS; IMPLEMENT GDP GUIDELINES FOR ALL CRITICAL DOCUMENTS SUCH AS ANALYTICAL TEST METHODS, CERTIFICATE OF ANALYSIS, PROTOCOLS, CHANGE CONTROL ASSESSMENTS, PRODUCT AND SAMPLE LABELS TO ENSURE COMPLIANCE WITH REGULATIONS US FDA GLP 21 CFR PART 58, CGMP 21 CFR PART 211 AND WHO ANNEX 5. 1020 TRAVEL REQUIRED.