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We are growing, grow with us!

PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. 
 
We are currently looking for an experienced Senior Specialist for the Development Consulting & Scientific Affairs division for PharmaLex US. The successful candidate supports DCS projects and team members in the areas of project management, document preparation, submission management and client relationships.
 
PharmaLex is a proud to be an equal opportunity employer.  We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce.  We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

Senior Specialist, Development Consulting & Scientific Affairs


Your Job

  • With minimal guidance develop and management project work plans based on agreed client deliverables and timelines
  • Work with assigned internal teams to ensure alignment on client objectives and drive timely completion of deliverables keeping project lead and client contacts informed as appropriate regarding progress
  • Maintain project documents in an organized manner
  • Review submission files and make minor formatting adjustments if needed prior to sending to RegOps
  • Update/Create Submission Content Trackers for RegOps Specialist to utilize when building the submission
  • Provide final submission packages
  • Work with key client contacts to resolve minor issues and maintain appropriate frequency of contact with client
  • Inform Managers/Partners when there are changes in scope or plan
  • Identify opportunities for follow-up on work within current projects, as well as outside current projects
  • Participate in BD activities with new potential clients including client calls and presentations and proposal development  
  • Show familiarity with all of PLX’s offerings
  • Other duties as assigned

Your Profile

  • Bachelor’s degree in Life Science or Chemistry-related fields with 3-5 years’ experience; or equivalent combination of education and experience
  • Firm understanding of key terminology of drug development and FDA regulations in some areas, and some regulations around the globe
  • Can successfully navigate 21CFR regulations, FDA, ICH and EU guidance documents online
  • Knowledge of all phases of research (pre-clinical through Phase IV)
  • Ability to adapt under regularly changing conditions
  • Very good command of English, written and verbal
  • Outstanding organization, analytical, and problem-solving skills, pharmaceutical project coordination or management are strongly preferred
  • Excellent written, verbal and presentation communication skills



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.
 

Agencies only by prior agreement for the specific job opportunity.