Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Country Approval Specialist Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our global team youll have the opportunity to participate in the management and preparation review and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist youll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
What Youll Do:
Prepares reviews and coordinates under guidance local regulatory submissions (MoH EC additional special national local applications if applicable e.g. gene therapy approvals viral safety dossiers import license) in alignment with global submission strategy.
Provides under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates under guidance with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities as required in accordance with agreed timelines.
Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years).
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently under direction as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves
Required Experience:
IC
Country Approval Specialist FSP Germany (mfd) • Munich, Bavaria, Germany
Job Openings German Digital Marketing Specialist Advisor w/ Relocation Bonus & Career Growth!.About the job German Digital Marketing Specialist Advisor w/ Relocation Bonus & Career Growth!.Are you ... Mehr anzeigen
Do you want to boost your career and collaborate with expert, talented colleagues to solve and deliver against our clients' most important challenges? We are growing and are looking for people to j... Mehr anzeigen
Als prämierter Engineering - Dienstleister sind wir in zukunftsweisende und spannende branchenübergreifende Entwicklungsprojekte national und international involviert.Haben Sie Interesse daran, in ... Mehr anzeigen
Echte Finanz-Fachkräfte sind rar, sehr gefragt und dementsprechend hoch ist ihr Marktwert.Egal ob im Bereich Accounting, Controlling, Corporate Banking, Interim-Management, Treasury oder Risk-Manag... Mehr anzeigen
Location: Remote within Germany; Munich Area preferred (team office).German charity organization that is part of the international Street Child network, committed to ensuring every child has access... Mehr anzeigen
Location: Remote within Germany; Munich Area preferred (team office).German charity organization that ispart of the international Street Child network, committed to ensuring every child has access ... Mehr anzeigen
Sales Account Development Specialist – Polnisch (m/w/d).Unser Kunde ist ein weltweit führendes Unternehmen in der Elektronik- und Halbleiterbranche.Um das nachhaltige und solide Wachstum der vergan... Mehr anzeigen
We are looking for a Global Mobility Expert (m/f/d) to establish and scale our global mobility function from scratch - focusing on employee moves to/from Germany but supporting all nationalities an... Mehr anzeigen
Starte mit Drive in Deine Zukunft!.Vollzeit 📄Unbefristet 🗓️ab sofort.Innendienst für Deine potenziellen Zielkunden, inkl.Angebots- & Kalkulationsarbeit, Vorbereitung und/oder Präsentation der... Mehr anzeigen
Bei Parkster stehen wir nicht still.Unser Expert Services Team entwickelt sich gerade von einer stark operativen Organisation hin zu einem modernen, kundenorientierten Bereich mit klarem Fokus auf ... Mehr anzeigen
SAP Authorization Consultant (w|m|d).Der ADAC ist immer in Bewegung und da, um zu helfen - dabei decken wir die unterschiedlichsten Bereiche ab, wie z.Versicherungen, Reisen und medizinische Unters... Mehr anzeigen
Payment Specialist Mastercard & Visa Schemes (m/w/d).Der Tribe Payment Processing & Administration entwickelt und betreibt Lösungen mit Schwerpunkt des Debit-/Kreditkarten-Processings, Wero und für... Mehr anzeigen
Wir suchen ab sofort für den Ausbau unseres Teams in Haar bei München einen Client Services Specialist (m/w/d) in Vollzeit.Eigenständiges Abarbeiten des Tagesgeschäftes.Erstellen von Auswertungen z... Mehr anzeigen
Diese international aufgestellte Top‑Einheit hat am Münchener Standort einen echten Partner‑Slot im Bereich Corporate/International Tax und sucht zum weiteren Auf- und Ausbau einen ambitionierten K... Mehr anzeigen
Cybersecurity Assurance Specialist (m/w/d).Als mittelständisches Unternehmen und verlässlicher Partner der Industrie liefert Schmitt Engineering umfassende technische Expertise.Unsere Tätigkeiten e... Mehr anzeigen
Für unseren Unternehmensbereich Compliance suchen wir zum nächstmöglichen Zeitpunkt eine engagierte Persönlichkeit, die den weiteren Ausbau und die nachhaltige Verankerung unseres Compliance-Manage... Mehr anzeigen
Als erfolgreiche Captive Bank für Finanzierungslösungen gehören wir zum bedeutenden Renault Konzern.Wir sind die Triebfeder zur Unterstützung des mobilen Wandels hin zu neuen Mobilitätslösungen, El... Mehr anzeigen
Du erklrst komplexe fachliche Inhalte verstndlich und kannst Kunden strukturiert durch Themen fhren.Du erkennst die fachlichen und regulatorischen Anforderungen von Kunden und entwickelst daraus pa... Mehr anzeigen
Client Services Specialist (m/w/d) – Vollzeit.Eigenständiges Abarbeiten des Tagesgeschäftes.Erstellen von Auswertungen zur Vertriebsunterstützung.Nachhalten und Einhaltung der individuellen Qualitä... Mehr anzeigen
Munich, Germany, On-site, Full-Time, Monday-Friday.Verification Specialist – Cards (w/m/d).Munich, Germany, On-site, Full-Time, Monday-Friday.We’re looking for a Verification Specialist to join our... Mehr anzeigen
){kind=logo}