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Job Details

Regulatory Study Start Up - Contract UK

Company: Planet Pharma Staffing Limited
Location:
Reference: AB14156
Closing Date: 23 Jan 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

If you would like to find out more information, please send a copy of your most up to date resume to Ashleigh Batchen at Planet Pharma: abatchen@planet-pharma.co.uk Or call on +44 (0) 203 868 1001

Requirements:

Job title: Regulatory Study Start Up

Location: Office-based in either Reading or Edinburgh

Contract length: 6 months

Start date: As soon as possible

FTE: 1.0

 

Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget, and resources

 

Responsibilities:

·        Oversee the execution of Start Up (including pre-award/bid defence activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines.

  • Develop, implement, and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
  • Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Work with Quality Management to ensure appropriate quality standards for the duration Start Up (or Maintenance, as applicable).
  • Mentor and coach colleagues as required.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project specific information.
  • May take a lead role in developing long standing relationships with preferred Quintiles customers.
  • Deliver presentations/training to clients, colleagues, and professional bodies, as required

 

Requirements:

  • Bachelor's degree in life sciences or related field with 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role; or equivalent combination of education, training, and experience
  • Strong negotiation and communication skills with ability to challenge
  • Excellent interpersonal skills and strong team player
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
  • Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
  • Demonstrated proficiency in using systems and technology to achieve work objectives
  • Good regulatory and/or technical writing skills
  • Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
  • Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills
  • Ability to exercise independent judgment taking calculated risks when making decisions
  • Good presentation skills
  • Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
  • Excellent understanding of study financial management
  • Proven ability to work on multiple projects balancing competing priorities
  • Eligible to work in the EU

Please note that this role is on a contract basis in the UK 

 

Key words: regulatory, study, start-up, submissions, CRO, clinical, trials, start, study, regulations, MHRA, FDA, EU, reading, edinburgh, scotland, united kingdom, contract

Apply for this job: Regulatory Study Start Up - Contract UK

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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