pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

Senior Manager, Development Consulting & Scientific Affairs (DCS)


Your Job

  • Independent project lead, including project coordination, budget control and close communication with the client and/or competent authority and/or partner companies

  • Support the Director Development Consulting & Scientific Affairs UK with the development & compilation of proposals

  • Support the Director Development Consulting & Scientific Affairs in the organization of the DCS UK VDC

  • Provide scientific knowledge and advice to clients

  • Represent the company in external events and client meetings

  • Support in the set-up and review of nonclinical and clinical development programs for medicinal products

  • Preparation of regulatory documents for the investigation and approval of medicinal products for human and veterinary use according to regulatory requirements in the EU and non-EU international markets, e.g.

    • Strategic development consulting / gap analysis / development planning

    • Clinical study documentation (protocols, investigator’s brochure, clinical study reports)

    • Nonclinical and clinical modules for CTD

    • Paediatric Investigation Plans (PIP) / Pediatric Study Plans (EU / US)

    • Environmental risk assessments (EU) / Environmental assessments (USA/Canada)

    • Literature searches for all kinds of regulatory and scientific documents

    • Scientific advice documentation (briefing books, presentation for meeting with authorities)

    • Preparation of product-related scientific texts and publications (expert statements, academic research articles, product monographs)

    • Other pre-authorisation activities, e.g. orphan designations and PRIME in Europe.

  • Assessment of efficacy, safety and benefit-risk of medicinal products for regulatory purposes,

  • Providing project-related or general regulatory trainings to the other group members and to the client’s project team

  • Provision of project management for own or other DCS or related PLX projects

  • Support of QM system at PharmaLex

Your Profile

  • Successful completion of at least a Bachelors or Masters Degree or equivalent in pharmacy or other natural sciences
  • Autonomous, concentrated and high-quality work
  • Ability to work in a team
  • Sense of responsibility
  • English language fluency, written and spoken
  • Ability to supervise team members at manager level
  • Strong project management skills

We offer

  • 25 days holiday plus bank holidays (increasing to 27 days after qualifying service)
  • 8% employer pension contribution 
  • The role can be based at any of our UK locations with flexibility to work remotely
  • An opportunity to work within an organisation with a positive work/life balance environment 
  • Continuous development opportunities through knowledge and experience as well as training



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:


Ms / Mr Pietropaolo
Manager Human Resources UK

 

Agencies only by prior agreement for the specific job opportunity.