Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Technical Manager, Regulatory Affairs - Office or Home Based - EMEA-136389

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge,
Reference: 136389
Closing Date: 07 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD has an exciting new vacancy for a Technical Manager.   This position sits within the Regulatory Affairs department at PPD, and will provide technical expertise and guidance to support the Regulatory Affairs business.  The position can be home or office based in EMEA. ...

Requirements:

PPD has an exciting new vacancy for a Technical Manager.

 

This position sits within the Regulatory Affairs department at PPD, and will provide technical expertise and guidance to support the Regulatory Affairs business.  The position can be home or office based in EMEA.  

 

In this role, you will:

-provide technical expertise and guidance to Regulatory Affairs in refining and automating business processes in conjunction with system needs

-Assesses technical issues with current systems and processes and evaluates systems, and/or upgrades to systems that could meet future business needs for Regulatory Affairs

-Gather, analyzes and document user requirements for various business initiatives

-Liaises with RA, IT, and other business units as needed, to ensure requirements are appropriately translated into design specifications for systems

-Serve as lead for the department on significant matters relating to system and support issues and opportunities, including budget development

Qualifications

Education and Experience Requirements

 

  • Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills and abilities to perform the job
  • 8 years relevant technical experience and business knowledge, or equivalent combination of education, training, and experience
  • Experience with RIMS (regulatory information management & systems), including background in evaluating, implementing, validating, document management systems and/or regulatory submission planning & publishing tools.
  • Awareness of IDMP (Identification of Medicinal Products) is highly desirable

 

Required Knowledge, Skills and Abilities:
  • In-depth knowledge of regulatory systems and processes, including applicable SOPs/ ICH GxP, current regulatory regulations, ICH specifications, and local regional guidelines
  • Advanced knowledge of regulatory information management, document management, document & submission publishing xEVMPD/IMPD, etc., concepts and systems, and workflow/process automation concepts and tools
  • Ability to analyze existing processes and systems, and propose/drive/lead appropriate change that measurably maintains and/or improves quality and efficiency of same
  • Good business understanding of regulatory and clinical systems
  • Client-focused approach with strong interpersonal skills
  • Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices
  • Ability to independently assess business needs and work with team members
  • Ability to independently learn new technologies and review/analyze competitive environment
  • Exceptional organizational skills and effective interpersonal skills
  • Exceptional analytical ability and problem-solving capabilities
  • Ability to  lead and motivate a cross-functional team
  • Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
  • Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
  • Strong negotiation skills
  • Familiarity with financial, budgeting and reporting tools
  • Excellent grammatical and exceptional communication skills, both written and oral
  • Detail-oriented, thorough, and methodical
  • Ability to create and follow timelines and conduct long-range planning
  • Ability to multi task and adapt to changes in work duties, responsibilities, and requirements
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. 
  • Ability to communicate information and ideas so that others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interact with others to obtain or relate information to diverse groups
  • Performs a range of variable tasks as dictated by demands and changing conditions with little predictability as to the occurrence. 
  • Ability to perform under stress, and to multi-task
  • Regular and consistent attendance.

Apply for this job: Technical Manager, Regulatory Affairs - Office or Home Based - EMEA-136389

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.