Quintiles cerca Global Regulatory & Start-Up Lead/Manager, based in EMEA (Rif. 1409334)

July 18, 2014 by · Comments Off on Quintiles cerca Global Regulatory & Start-Up Lead/Manager, based in EMEA (Rif. 1409334)
Filed under: Regulatory Affairs 

About Quintiles:

Quintiles logo

 

 

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

 

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.  To learn more about Quintiles, please visit www.quintiles.com

 

We continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We have a rewarding opportunity for a Global Regulatory & Start-Up Manager!

 

This is a global position and is flexible concerning the location.

 

PURPOSE
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget and resources.

 

Responsibilities

  • The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
  • Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
  • Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
  • Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
  • Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
  • Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
  • Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
  • Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
  • Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
  • May take a proactive role in developing long standing relationships with preferred Quintiles customers.

Qualifications

 REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

    • Good negotiating and communication skills with ability to challenge
    • Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
    • Good regulatory and/or technical writing skills
    • Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
    • Ability to exercise independent judgment taking calculated risks when making decisions
    • Good leadership skills, with ability to motivate, coach and mentor
    • Good organizational and planning skills
    • Good presentation skills
    • Understanding of study financial management
    • Ability to establish and maintain effective working relationships with co-

workers, managers and sponsors.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or related field with 7 years’ relevant experience including demonstrable experience in an international role; or equivalent combination of education, training and experience.

Primary Location

  • Great Britain

 

Other Locations

  • Italy, Spain, France, Germany, Netherlands

Organization

  • GBR02 – UK Product Development

How to apply

To apply for this job please visit the following URL:https://quintiles.taleo.net/careersection/10000/jobdetail.ftl

MedPace Italy cerca un Regulatory Submissions Coordinator con 2 anni di esperienza

June 16, 2014 by · Comments Off on MedPace Italy cerca un Regulatory Submissions Coordinator con 2 anni di esperienza
Filed under: Clinical Research, Regulatory Affairs 

MedPace Italy, CRO internazionale in forte espansione in Italia, sta cercando un Regulatory Submissione Coordinator.

Ecco la Job Description che puoi trovare direttamente sul sito web MedPace:

 

Location: Italy
Office: Office based, Milan
Full-time or Part-time: Full-time

DESCRIPTION OF JOB DUTIES

  • Prepare, review, submit and file clinical trial applications to national regulatory agencies;
  • Provide updated forecast of local submission and approval timelines;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Collect the required investigator and regulatory documents from the sites ensuring documents meet the required specifications
  • Interact with contracts lead to negotiate and execute site-specific country template contract
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise study team on changing regulations and compliance requirements; and
  • Track submissions and ensure timely filing of documents.

QUALIFICATIONS/REQUIREMENTS

  • Bachelor’s degree in life sciences;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation and contracts;
  • At least two years of startup experience as a Regulatory Submissions Coordinator;
  • Excellent organization and communication skills;
  • Knowledge of Microsoft® Office;
  • Fluency in English and local language.

 

WHAT TO EXPECT NEXT
We look forward to receiving your application in english. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

 

HOW TO APPLY

To apply please access our career opportunities on our website at: www.medpace.com and apply for this position through our system by uploading your CV in English. A member of our recruitment team

will review your qualifications. If interested, you will be contacted for an interview.

For more information please visit our website: www.medpace.com

 

 

 

Applica ora per unirti al team MedPace Italy!

Study Start-up Associate (Contracts)

March 6, 2013 by · Comments Off on Study Start-up Associate (Contracts)
Filed under: Clinical Research, Regulatory Affairs 

A leading biopharmaceutical company  is looking for an enthusiastic and experienced  Study Start-up Associate (Contracts)

Role and Responsibilities

– Prepare study-specific Clinical Trial Agreements templates with investigators and institutions for study management teams
– Negotiate budget costs and contract language with the appropriate party at the sites
– Assist with developing a budget template and determining reasonable procedure costs after thorough reading of the protocol
– Liaise with CTA Department to resolve individual contract language regarding issues that fall outside the allowable contract terms
– Maintain status tracking tool for individual sites for each study
– Maintain open communication and participate in regular meetings/teleconferences with study teams

What is Required

– BA/BS with at least 3 years of experience in pharmaceutical clinical research including contract preparation and negotiation
– Expert knowledge of ICH and GCP guidelines
– Good communication skills are mandatory
– Demonstrated ability to be customer oriented to the investigator and site personnel in order to achieve high customer satisfaction levels
– Demonstrated ability to prioritize and manage multiple complex tasks
– Demonstrated ability to attend to detail and solve problems
– Demonstrated ability to work with multiple study sites in several therapeutic areas                                                                                                                                                                                              – English written & spoken at fluent level

What is offered

This is a great opportunity to join an international company working on a cutting-edge projects!                                                                                                                        The position is Office based (Milan) or Home base (previous experience required)
Full time for 6 months with possibility of Permanent Contract
Interesting Salary

If you’re interested , please send an English Cv at alessandra.arensi@docsglobal.com quoting the reference AS- 2400.

Project Assistant Categorie Protette

November 5, 2012 by · Comments Off on Project Assistant Categorie Protette
Filed under: Clinical Research, Miscellaneous, Regulatory Affairs, Uncategorized 

Project Assistant Categorie Protette

 

Una delle migliori CRO Globali sta cercando un Project Assistant a tempo indeterminato office based nei loro uffici di Milano, per supporto amministrativo ai progetti di clinical research.

 

La persona ricercata appartiene alle categorie protette e ha eccellenti doti comunicative, organizzative, e’ motivato/a, flessibile e un approccio professionale.

 

Responsabilita’:

1) Fornire supporto amministrativo generale a tutti i membri dei Team di progetto.

2) Mantenere project files e documentazione in ordine.

3) Coordinare i viaggi dei membri del Team

4) Assistere nella organizzazione dei meetings.

5) Mantenere i database.

6) Altri compiti ad-hoc associati alla gestione dei clinical trials e office administration dove richiesto.

 

Il candidato ideale ha ottime competenze informatiche, incluso Microsoft Office. E’ una persona motivata e con attitudine positiva, con doti comunicative e interpersonali eccellenti. Il candidato ideale ha anche forti doti organizzative e attenzione ai dettagli, e’ multitasking e sa lavorare autonomamante e in team.

E’ richiesta la fluenza in Italiano e in Inglese.

 

La ricerca e’ riservata ai soli iscritti alle categorie protette ai sensi della legge 68/99.

Vi prego di inviare un cv aggiornato a sergio.carito@secpharma.com.

Vi prego di far girare questo annuncio per dare una ottima opportunita’ di lavoro a quanti conoscete che siano in linea con il profilo e ne possano beneficiare.

 

Sergio Carito

Consultant Pharmaceutical, CRO, Healthcare & Biotech Division

Italy and Europe

Tel: +44 (0) 207 255 6665

sergio.carito@secpharma.com

http://uk.linkedin.com/in/sergiocarito

 

SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business

Regulatory Officer OTC Specialist – Tempo indeterminato

August 15, 2012 by · Comments Off on Regulatory Officer OTC Specialist – Tempo indeterminato
Filed under: Regulatory Affairs 

NonStop sta collaborando con una compagnia farmaceutica internazionale che produce prodotti OTC ed etici. Il reparto OTC e’ in veloce crescita, e la compagnia ha aperto un nuovo ruolo di Regulatory officer che sara’ di sostegno al Regularory Manager.

La compagnia e’ in cerca di una persona che abbia un esperienza di circa 18 mesi nel campo OTC e voglia progredire in questo ramo. Questo ruolo e’ a tempo indeterminato e include un ottimo salario con altri benefit aziendali.

Le richieste Read more

Site Start-Up Specialist Office-Based Milano

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Il lavoro che hai sempre desiderato nella ricerca clinica

December 26, 2011 by · 8,790 Comments
Filed under: Clinical Research, Regulatory Affairs 

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