Regulatory Process Support (part time job) Job

Requisition ID: LIB000120

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


 


MSD’s Animal Health (MAH) division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.


 


 


SUMMARY OF POSITION:

To assist the Regulatory Affairs team with the efficient day to day administrative running of the department.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Regulatory Affairs Duties



  • Maintain and update the departmental scanned filing system, ensure that documentation is easily accessible.

  • Give assistance to the Regulatory Affairs team in order to maintain and update the departmental database(s).

  • Act on behalf of the Regulatory Affairs team in order to respond to straightforward correspondence (both internal and external).

  • Preparing and submitting regulatory information for the Internet and Intranet

  • Provide support with proof reading new or substantially changed packaging items

  • Responsible for photocopying and binding Regulatory Affairs data packages which need to be sent externally

  • Assist in finding product information from Regulatory Affairs databases in response to requests from Intervet International.

  • Creating purchase orders and invoice processing for RA & PV

  • Assist with data sheet upload to NOAH website and creation of NOAH Compendium as required

  • Budget variation forecasting

  • Quarterly regulatory reporting

  • Yearly reports i.e. antimicrobial reporting to VMD, Licence reporting for annual fees, Virbac reclaims

  • Order stationery for RA & PV

  • Process the post for RA & PV

  • Take minutes from the RA meetings.


Safety, Health and Environment
All employees have a responsibility:



  • To cooperate with supervisors and managers to achieve a safe and healthy workplace and protect the environment

  • To take reasonable care of themselves and those who may be affected by their actions or omissions

  • To follow safe operating instructions for all tasks and equipment

  • To use the right tools and equipment specified for the task

  • To use the correct personal protective equipment required

  • To report any defects or workplace hazards to supervisors or managers immediately

  • To report all accidents, incidents and near misses.


There are no specific SH&E responsibilities required of the Regulatory Affairs Administrative Assistant.

Qualifications

BACKGROUND REQUIREMENTS

Knowledge, Skill And Experience Required



  • Good knowledge of the English language.

  • Good communication skills.

  • Knowledge of word processing (WORD, EXCEL, ACCESS, OUTLOOK and POWERPOINT) and ability to learn new software as required.

  • Methodical, precise and organised – ‘’good eye for detail’’.

  • Willingness and ability to learn new software packages as requested (i.e. SRM).


Decision Making Authority

Independent decisions - Within constraints imposed (deadlines etc.) the Administrator makes all the necessary decisions relating to the planning and organisation of his/her work routine.

Planning, Organising And Controlling



  • The Administrator plans his/her own routine to ensure that requested work is performed within set timetables.

  • Organises workload in response to departmental and Company priorities.

Major Challenge Of Job



  • Achieve the required objectives as quickly and efficiently as possible in order to ensure a good performance of the departments concerned.

  • Increase knowledge of the regulatory affairs, pharmacovigilance and marketing.

 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 


 


Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.




Job: Library/Information Services
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD
Company
MSD
Posted
03/25/2018
Type
Full time
Location
Milton Keynes, ENG, GB