Description Position at Premier Research Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.We?re looking for an exceptional Regulatory Start Up Project Manager II, Study Start Up Project Lead to bring your passion to our team.
You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority.
Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the worldAt Premier Research, we are science-minded and heart-centered.
Join us.What you'll be doing:
Education to university degree level (pharmacy, medicine or related natural sciences is a plus)Minimum of 7 years professional experience, including at least 4 years of previous experience as Regulatory Start-up Manager at a local/country level, for newly awarded studies containing countries from the same region, and may take a multi
- region study in Start-up under supervision, or maintenance studiesAt least 2 years of hands-on experience in global studiesExperience working on ample number of countries in global studiesWorking knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and start-up proceduresKnowledge of ICH / GCP regulations / country specific regulations as applicableAbility to work accurately and to interpret the relevant directives and guidelinesWorking knowledge of professionally recognized tools for planning and management of scope, timeline, resources, and budgetFluent verbal and written EnglishAbility to fulfill objectives such as identification with the interests of sponsors, special focus on the wishes of the sponsors, completion of projects within the agreed budget and timelinesExcellent team player, collaborative and able to build an effective teamAbility to multitask and work effectively in a fast-paced environment with changing prioritiesComplies with all company requirements, including timesheet compliance and use of tools and plansDevelops and maintains strong relationships with peers in other departments to provide awareness of future issues and to promote collaborative working and efficient problem solvingStrong verbal and written communication and negotiation skillsExcellent organizational and time-management skills, able prioritize work to meet deadlinesAccountable, dependable and strong commitmentIs customer service focused in approach to work both internally and externallyMaintains a positive, results orientated work environment#LI-RS1