SSU & Country Submission Specialist (Level II or Senior)

JOB SUMMARY

This is an exciting opporitny to join an industry leading CRO as a SSU & Country Submission Specialist. You will be responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager. 

This is a great opportunity to combine both Site Activation (approx. 30%) and Country Submissions activities (approx. 70%) which allows you to expand on your skill set.

Responsibilities:

• Prepare ongoing submissions, amendments, and periodic notifications required EC and RA and other local regulatory authorities.
• Perform Country Start-Up Advisory duties
• Local Site ID and Feasibility Support
• Local Investigator Contract and Budget Negotiator

REQUIREMENTS

• Bachelor’s Degree or equivalent, 
• Proven understanding of theclinical trial process across Phases II-IV and ICH GCP. 
• Experience inclinical protocols and associated study specifications. 
• Proven expertise of theclinical trial start-up process. 
• Experience in managingexternal vendors
• Strong organizational skills with ability to handle multiple tasks effectively. 

Ability to manage multiple project budgets with increased complexity and value. 

LOCATION

Home based, in Denmark (we could consider candidates based outside of Denmark, providing you speak fluent Danish)

DURATION

Direct Hire / Permanent

SALARY

Annual Competitive.

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

• If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on jsmith@planet-pharma.co.uk
• If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!