最新公告

辉瑞公司最新招聘信息（09-04-30）

发布日期：2009-4-30

辉瑞公司最新招聘信息

        以下三个职位是辉瑞公司目前面向09应届硕士毕业生招聘的，职位介绍及简历收集邮箱如下：

职位一：注册专员/助理，简历收集邮箱：talent.china@pfizer.com
Position:      Registration  Officer/Associate  注册专员/助理
Working  Location:    Beijing
JOB  SUMMARY
The  Registration  Officer  /Associate  (RO/RA)  assists  with  the  regulatory  maintenance  of  a  portfolio  of  products.    This  includes  the  preparation  of  regulatory  submissions  to  the  Chinese  authorities  for  registration  of  new  products,  variations  to  marketed  products  and  clinical  trial  notifications,  when  required.  The  RO/RA  will  assist  the  Registration  Managers  on  specific  projects,  and  in  some  instances  will  be  responsible  for  their  own  projects.  The  RO/RA  ensures  that  each  project  operates  within  the  set  timeframes,  is  conducted  to  the  highest  standards  of  quality  and  is  in  accordance  with  local  and  international  regulatory  agency  requirements  and  Pfizer  Standard  Operating  Procedures.  The  RO/RA  may  also  be  required  to  assist  on  special  projects  for  the  Regulatory  Affairs  Group.
KEY  RESULT  AREAS  &  JOB  ACTIVITIES  /TASKS
1．  Responsibilities
-    -                Prepare  the  regulatory  submissions  for  registration  of  new  products,  variations  to  marketed  products  and  clinical  trial  applications  where  required
-    -                Critically  analyze  data  packages  for  regulatory  compliance  and  identify  discrepancies  in  data  presented  and  request  additional  data
-    -                Develop  an  overall  perspective  of  registration  projects
-    -                Prepare  responses  to  deficiency  letters  and  ensure  that  these  and  other  data  requirements  are  submitted  to  regulatory  agencies  within  the  stipulated  or  agreed  timeframes
-    -                Maintain  contact  with  officials  of  Chinese  regulatory  agencies  to  determine  regulatory  requirements,  ensure  compliance  with  the  regulations  and  expedite  approvals
-    -                Maintain  and  update  the  Local  Product  Document  (labeling)  in  accordance  with  relevant  regulations  and  PPG  SOPs
-    -                Maintain  an  up  to  date  knowledge  of  the  relevant  legislation  in  China
-    -                Maintain  adequate  product  knowledge  to  ensure  prompt  and  professional  responses  to  queries  relating  to  company  products
-    -                Provide  regulatory  advice  to  company  personnel  as  required
2.    2.                Special  Projects
-    -                Be  required  to  participate  on  special  projects  for  the  Regulatory  Affairs  Group
3.    3.                Market  Support
-    -                Attend  Regulatory  Affairs,  Medical  Department  and  other  internal  meetings  as  required
-    -                Provide  a  resource  for  other  sections  of  the  company  for  specified  therapeutic  areas
4.    4.                Personal  Development
-    -                Complete  the  Pfizer  PRE  Safety  Reporting  Process:  Overview  training  module  in  the  set  timeframe
-    -                Complete  GDMS  Training
-    -                Attend  and  actively  participate  in  personal  development  courses  as  required
-    -                Attend  training  in  specific  therapeutic  areas  as  required.
-    -                Participate  in  Regulatory  Affairs  and  Medical  Department  projects  and  workshops
BACKGROUND  REQUIREMENTS
-    -                Tertiary  qualifications  in  pharmacy  or  a  science  degree  with  a  pharmacology  major
-    -                Good  working  knowledge  of  international  and  local  regulatory  guidelines  and  codes
-    -                Proficiency  in  Basic  Microsoft  Word,  PowerPoint  and  Excel
COMPETENCIES  REQUIREMENTS
-    -                Experience  in  more  than  one  therapeutic  area
-    -                Previous  industry  experience
-    -                Familiarity  with  the  use  of  databases
-    -                Sustain  Focus  on  Performance
-    -                Create  an  Inclusive  Environment
-    -                Encourage  Open  Discussion  and  Debate
-    -                Manage  Change
-    -                Develop  People
-    -                Align  Across  Pfizer

职位二：临床试验助理，简历收集邮箱：job-c2.china@pfizer.com
Position:      Clinical  Trial  Assistant
Working  Location:    Beijing
JOB  SUMMARY
The  Clinical  Trial  Assistant  (CTA)  provides  full  support  in  clinical  trial  documents  management  to  study  teams  during  the  preparation,  conduction  and  close-out  of  clinical  trials.  This  includes  scanning,  uploading  essential  documents  into  Electronic  Library  and  Records  Archive  (ELARA),  conducing  Index  QC,  scanning  Case  Report  Forms  (CRFs),  Trial  Master  File  (TMF)  Library  Management,  and  other  tasks  as  assigned  by  the  Clinical  Operations  Manager  (COM).    The  CTA  will  also  support  clinical  supply  coordinator  in  clincal  supply  management,  such  as  drugroom  management,  clinical  supply  distribution  to  sites,  etc.
The  CTA  is  an  in-house  position  and  reports  to  the  Clinical  Operations  Manager  (COM).  She/he  must  be  able  to  work  independently,  as  well  as  in  a  collaborative  team  setting,  on  assigned  responsibilities.
KEY  RESULT  AREAS  &  JOB  ACTIVITIES/TASKS
1.  Clinical  Trial  Documents  Management
-    Process  clinical  trial  documents,  including  scanning,  image  QC,  uploading  documents  to  ELARA  and  conducting  Index  QC  where  necessary
-    Assist  Clinical  Research  Associates(CRAs)  in  setting  up  investigator  Site  Master  File  (SMF)
-    Trial  Master  File  Library  Management
2.  Clinical  Supply  Management  during  Trial  Conduct  Phase
-    Select  appropriate  couriers  and  ship  clinical  drugs  to  institutional  sites.
-    Perform  and  coordinate  clinical  supply  site-to-site  transfer  when  necessary.
-    Work  with  CRAs  on  drug  return  and  perform  final  drug  reconciliation  at  the  protocol  level.
-    Work  with  Dalian  PGM  and  coordinate  drug  destruction.
3.  Drug  Room  Management
-      Perform  administrative  check  of  the  air  temperature  and  humidity  of  the  drug  room  at  regular  intervals  as  instructed.
-    Coordinate  with  Human  Resource  department  and  company  security  to  prevent  fire  and  infestation  by  insects  or  vermin.
-    Inform  relevant  supply  owners  of  any  temperature  deviations  from  the  required  condition  recorded  on  the  Storage  Condition  Required  Form.
-    File  and  archive  all  supply-related  forms  in  the  drug  room.
-    Continuously  review  the  procedures  and  forms  related  to  supply  management  and  make  amendment  /update  whenever  required.
BACKGROUND  REQUIREMENTS
1.  Education
-    College  Degree  or  above
-    Medical,  or  Pharmacy,  or  other  life  science  education  background  preferred
2.  Working  Experiences
-    Prefer  to  have  had  experience  in  assisting  with  clinical  trial  and  regulatory  filings  documents
-    Preferably  at  least  1  year  experience  as  a  clinical  trial  assistant  or  secretary
-    Understanding  of  medical  and  clinical  trial  documents  terms
-    Proficiency  in  Basic  Microsoft  Word,  PowerPoint  and  Excel
-    Familiar  with  use  of  databases,  knowledge  of  Access  is  a  plus
-    Good  English  skills  in  speaking,  reading,  and  writing

职位三：质量标准专员，简历收集邮箱为：recruitment.china@pfizer.com
Position:    Quality  Standards  Officer
Working  Location:    Beijing
Job    Summary
The  Quality  Standards  Officer  (QSO)  works  in  QS  team  to  provide  support  on  global  SOP,  policy  and  system  implementation  and  ensure  the  compliance  at  WPO.  The  QSO  is  responsible  for  communicating  WPO  medical  staff  with  global  SOP,  policy  and  system  information  and  associated  training  requirement,  as  well  as  tracking  local  training  compliance  status.    In  case  of  audit  by  Worldwide  Regulatory  Affairs  and  Quality  Assurance  (WRAQA  QA),  the  QSO  acts  as  WPO  contact  in  providing  support  on  audit  activities  as  required.
In  addition  to  above  duties,  the  QSO  may  also  be  assigned  to  coordinate  special  projects  or  tasks  and  will  contribute  to  the  achievement  of  QS  team  and  Medical  Objectives.
KEY  RESULT  AREAS  &  JOB  ACTIVITIES  /TASKS
1.  Assist  in  Development  and  Implementation  of  Procedures,  Systems  and  Training
-  Assist  QS  team  in  tracking  local  Implementation  Guideline  (IG)  status  in  accordance  with  SOP  revision  or  as  business  need
-  Maintain  the  current  and  historical  version  of  IGs  on  Pfizer  P  drive
-  Process  the  uploading  of  IGs  to  eSOP  Portal  when  locally  approved
-  Assist  QS  team  in  providing  QS  perspective  review  comments  on  local  IG  development  and  revision,  and  ensure  it  is  in  compliance  with  global  SOP,  Policy  and  local  regulatory  requirement
-  Assist  QS  team  in  preparing  of  training  materials  of  local  IG  as  appropriate  and  facilitate  the  training  courses  running  at  WPO
2.  Collaboration  with  QRAQA  QA  Audit  Groups  and  Support  of  Audit/Regulatory  Inspections
-  Attend  the  preparation  meeting  with  functional  teams  at  WPO  when  audit  is  proposed,  support  QS  team  on  audit  readiness  activities  as  required
-  Coordinate  between  WPO  and  Corporate  audit  groups  to  support  on  audit  logistics,  report  distribution,  communication  of  local  processes,  updates  and  communication  of  final  results
-  Making  meeting  minutes/records  for  audit  exit  meeting  and  support  QS  team  on  tracking  audit  report  follow  up  activities  with  functional  teams
-  Maintain  WPO  audit  related  documents
-  Support  regulatory  inspections  as  per  the  Global  SOP  on  “Good  Clinical  Practice  and  Pharmacovigilance  Inspections”  and  respective  Local  Site  Action  Plan
3.  Training  System  Management
-  Process  the  ‘smart  request’  on  Power-2-Learn  (P2L)  system  for  medical  new  staff  or  staff  whose  position  changed,  based  on  the  job  role  confirmation  from  his/her  supervisor
-  Generate  monthly  tracking  form  on  job  role  assignment
-  Assist  QS  team  in  learning  activity  management  on  P2L,  namely  register  learning  event,  monitor  event  registration,  prepare  sign-in  roster  and  submit  completed  roster  for  P2L  entry.
-  Assist  QS  team  in  participating  in  local  CRA  workshop  organized  by  clinical  research  operation  team  and  tracking  the  CRA  certificate  status
-  Assist  QS  team  in  generating  kinds  of  training  analysis  reports  and  to  track  training  compliance  of  functional  lines.
4.  Others
-  Assist  QS  team  in  Induction/Orientation  of  New  Hires  of  Medical  Department
-  Assist  QS  team  in  preparing  and  tracking  quality  review  activities
-  Daily  check  QS  mailbox  for  any  of  queries  raised  from  medical  staff  and  forward  to  team  member  for  response
-  Update  and  maintain  the  QS  website  with  quality  related  document,  information  etc
EDUCATION  &  EXPERIENCE  REQUIREMENTS
1.  Educational  /Training
-  Educational：Bachelor‘s  Degree
2.  Working  Experiences
-  1  year  administrative  experience  in  medial  department  in  pharmaceutical  industry  demonstrating  the  following:
-  Thorough  knowledge  of  ICH  GCP  and  related  local  regulations
-  Understanding  of  the  processes  associated  with  clinical  development  and  regulatory  operations
COMPETENCIES  REQUIREMENTS
1.  Ability  Functional
-  Conscientious,  good  team  player
-  Must  be  independent,  pro-active,  self-motivated  with  strong  organizational,  interpersonal  and  communication  skills
-  Excellent  follow-up  skills.
-  Excellent  verbal  and  written  communication  skills  for  interaction  with  manager  and  colleagues
-  Proficient  in  both  verbal  and  written  Chinese  and  English
-  Demonstrated  proficiency  with  all  software  including  Outlook,  Word,  Excel,  and  PowerPoint  as  well  as  internet  applications  with  ability  to  learn  new  applications.
2.  Cultural  Competencies  (Leadership  Behaviors)
-  Sustain  Focus  on  Performance
-  Create  an  Inclusive  Environment
-  Encourage  Open  Discussion  and  Debate
-  Manage  Change
-  Develop  People
-  Align  Across  Pfizer