A pharmacist with over a year experience working with global pharmaceutical company "Novo Nordisk". With a strong educational background in pharmaceutical sciences and capable of supporting the development of innovative medicinal products. An effective team communicator and team player with the ability to build confidence.

Regulatory Affairs International Trial Management Labelling GMP GCP Real-World Measures qulaity project management  

Opdateret 20. marts 2018
Min uddannelse
2015 - 2018

MSc, Pharmaceutical Sciences

Københavns Universitet

Uddannelsesområde: Medicinal & Sundhed
Periode: oktober 2015 - januar 2018
2008 - 2014

Farmaceut

Anden uddannelsesinstitution i udlandet

Uddannelsesområde: Medicinal & Sundhed
Periode: august 2008 - august 2014
Min erhvervserfaring
2017 - 2018

Master Thesis Student

Virksomhedsnavn skjult

As a Master Thesis student, I gained a broad and international experience with medicines clinical study design, regulation, submission, and approvals by E.U. European Medicine Agency (EMA) and U.S. Food & Drug Administration (FDA). As well as obtained deep knowledge and experience within the regulation of the clinical trials, study design, and real world evidence (RWE) measured by patient reported outcomes (PROs). During writing and managing independently the master thesis project within regulatory affairs on "Fixed Dose Combinations – Regulatory Aspects And Real World Measures On Xultophy Therapy: Part I – Differences Of EMA And FDA Label Indications For FDC Products Approved Jan 2000 – Apr 2017. Part II – A novel Approach To Collecting Real-World Patient Reported Outcome Applied To T2DM FDC Users".

Managing the master thesis project:
• Collaborating and communicating with different stakeholders: supervisors, regulatory affairs professionals, and pharmacists
• Analyzing and reporting the master thesis results
• Writing effectively and independently the master thesis
• Designing a novel second part of the master thesis project by developing patient questionnaire dispensed to community pharmacies
• Comparing and finding disparity or alignment between two major medicine agencies (EU-EMA vs. US-FDA)
• Collecting real-world evidence (RWE) using patient reported outcomes (PROs)
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2017 - januar 2018
2016 - 2016

Regulatory Affairs Intern

Virksomhedsnavn skjult

Key functions (objectives of occupation):
? Responsible for questions received from EMA, FDA and Switzerland during insulin faster aspart MAA, NDA assessment and for the phase 3a programme - in close collaboration with regulatory professional/associate
? Provides support to the team regarding preparation of label document for non-EU countries
? Participates in relevant team meetings and cross-functional teams meetings
? Provides support to regulatory professionals regarding search for information related to regulatory requirements and competitor products
Arbejdsområde: Medicinal & Sundhed
Periode: august 2016 - december 2016
Mine kompetencer
Evner
gcp gmp international trial management labelling project management qulaity real-world measures regulatory affairs
Sprog på arbejdsniveau
arabisk dansk engelsk tyrkisk
Mine præferencer
Jobtype
Freelance Fuldtidsjob Ph.d. & forskning
Arbejdsområde
Medicinal & Sundhed
Geografi
Storkøbenhavn
Lønønske
40.000 DKK / måned
Kontakt mig!