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Responsible Person - Medical Scientific Advisor

Job Title: Responsible Person - Medical Scientific Advisor
Contract Type: Permanent
Location: Buckinghamshire, England
Industry:
Salary: £45000 - £55000 per annum + pension, healthcare, bonus
Start Date: July / August 2017
Reference: 69647-PHARM-JHY_1499434917
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: July 07, 2017 14:41

Job Description

Job title: Responsible Person - Medical Scientific Advisor
Job type: Permanent
Location: South Buckinghamshire, UK
Salary: £45,000 - £55,000 / year + comprehensive benefits package

Job Purpose

·Key responsibility for safeguarding product users against potential hazards
arising from poor distribution practices
·Assisting in the development of, and conduct of a variety of Medical Affairs
initiatives
·Provide technical / scientific consultation to both the Scientific and the
commercial teams to ensure accuracy and compliance with the standard and
local rules and regulations

Key Responsibilities

Working closely with the company distributor partner:

·Ensure compliance with the requirements of Good Distribution Practice (GDP)
·Ensure all GDP aspects of the quality management system are implemented and
maintained
·Ensure both the Company and the distributor partner follow EU and national
requirements for the import of licenced and unlicensed medicines into the UK
·Ensure the Company complaints and product defects or falsified products are
handled as required and set quarantine when needed
·Implement, update and audit internally company procedures relevant to the
area of Pharmaceutical wholesale
·Train company personnel when required on GDP quality processes and
requirements
·Manage the Supply Chain including S&OP process i.e Goods Forecasting, Supply
Planning, Quality Assurance and Regulatory interactions

Support Medical Affairs department:

·Advise on compliance issues, review materials to ensure all claims are
substantiated by scientific data and are in accordance with the ABPI/IPHA
Codes of Practice (for example those materials and arrangements related to
advisory boards)
·Work collaboratively within the brand team to provide strategic scientific
input into brand plans to develop an appropriate product strategy
·Attend scientific congresses and meetings to maintain therapy area knowledge
and to develop/maintain relationships with external customers
·Provide support to the Director, Medical Affairs in developing and
implementing Medical Affairs' initiatives to support the needs of the
company
·Participate in the training of company staff to meet the technical, medical
and interpersonal challenges of their roles
·Develop and review training documents to check medical accuracy and
compliance with regulatory requirements in order to deliver training to
commercial colleagues on such matters as therapy area awareness, competitor
data, and congress updates
·Provide scientific support to Marketing, Regulatory, Market Access,
Pharmacovigilance and Medical Information
·Provide and develop portfolio of data and medical/scientific input to HTA or
other market access submissions as required
·Provide scientific input & feedback on Investigators Initiated Trial
proposals
·Provide support to Medical field based staff

Qualifications and personal attributes

Essential

·Bachelor's degree in a relevant scientific discipline
·Proficient in GDP and regulations promulgated by the EMA or equivalent
regulatory Agencies
·Previous experience as Responsible Person or Qualified Person
·Excellent verbal and written communication and organisational skills
·Understanding of pharmaceutical industry
·Excellent interpersonal skills
·Good understanding of the ABPI Code of Practice
·Good team working skills
·Sound analytical skills

Preferred

·UK registered Pharmacist
·Previous experience in working in Medical Affairs