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Interim/Contract **Clinical Trial Data Publisher/Disclosure Lead** – one of 3 EU locations

Company: Advanced S&S (Medical / Clinical)
Location: Multiple UK / EU Locations
Reference: Oli/01355
Closing Date: 01 Jul 18
Type: Contract
Salary (£): Competitive
Benefits: On Application

Job Summary:

We have a 17-month interim opportunity for an Integrated Data Disclosure Planning Lead for a dynamic and expanding, international Biopharmaceutical company. This opportunity can be based in Brussels, Belgium, West of London, UK or Cologne, Germany.

Requirements:

We have a 17-month interim opportunity for an Integrated Data Disclosure Planning Lead for a dynamic and expanding, international Biopharmaceutical company. This opportunity can be based in Brussels, Belgium, West of London, UK or Cologne, Germany.

In collaboration with multidisciplinary teams of experts, you will drive the development & implementation of holistic asset/Therapeutic Area (TA) data disclosure plans, to enable timely, ethical & consistent disclosure of company-sponsored human subject research according to applicable regulations and in line with Company Policy.

KEY ACCOUNTABILITIES

  • Provide a clear vision of clinical data disclosure activities & processes at asset/Therapy Area (TA) level, communicating on the importance of adhering to applicable requirements and, beyond that, of forward-looking data transparency for bringing Value to Patients.
  • Maximize consistency across disclosure footprint, through establishing a clear line of sight from clinical development through study registry & results disclosure to publication & data sharing – by implementing asset/TA Integrated Data Disclosure Plans.
  • Oversee disclosure activities from planning to delivery, coordinating with Clinical Trial Registry & Results Disclosure Compliance Leads to ensure deliverables are of highest standard & in line with all applicable requirements.
  • Ensure effective implementation of disclosure-readiness principles throughout the clinical development & data generation process, for forward-looking transparency balanced with Intellectual Property (IP) protection needs – for the ultimate benefit of Patients.

MAJOR RESPONSIBILITIES

  1. Establish a framework for Integrated Data Disclosure Planning for company-sponsored studies, aimed at building clear oversight on data disclosure footprint across assets/TAs.
  2. Lead the development of asset/TA Integrated Data Disclosure Plans, incl. protocol registrations & results postings, in collaboration with multi-disciplinary teams of internal experts; Organize & chair Integrated Data Disclosure Planning forums.
  3. Establish & maintain robust communication interfaces across all stakeholders involved in the generation of disclosure plans & related deliverables – from Clinical Development to Medical Affairs to Patient Value Units.
  4. Manage the implementation of disclosure planning in accordance with Company Policy & external requirements.
  5. Review data disclosure deliverables for assets/TAs covered, to ensure they align with agreed IDDP and conform to highest standards.
  6. Create & maintain high degree of scientific expertise in asset/TA clinical development/research programs & related data generation.
  7. Keep oversight on budget allocated to disclosure activities for assets/TAs under responsibility.
  8. Support the Head of Clinical Trial Disclosure in ensuring the company meets expectations of continuously evolving requirements.
  9. An expert in clinical data disclosure & related governance, develop/broaden knowledge on disclosure topics & be a reference for internal stakeholders at asset/TA level; Support the Head of Clinical Trial Disclosure in implementing related training programs.

The ideal candidate will have at least 4 years of proven experience in research reporting functions e.g., in the field of Clinical Trial (Public) Disclosure &/or Scientific/Regulatory Writing. Will have minimum Master’s Degree in Biology, Pharmacology or Life Science; PhD preferred.

You would have in-depth knowledge & experience of regulations/guidelines/policies governing Clinical Trial Disclosure notably FDAAA & Final Rule and EU Clinical Trial Directive & Regulation; Advanced knowledge of ICH & GCP regulations. Understanding of statistical concepts in clinical research, methodology in the design, conduct & description of clinical studies, the structure & content of clinical documents (e.g., study protocols & reports), and how to analyse & describe clinical research results. Proven experience in Project Management. Excellent English and strong presentation skills.

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If you wish to apply for this role, please send your CV with a covering note to oli.dimitrov@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Oli in the London office on +44 (0)20 7801 3380.
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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Jobs in Belgium, Brussels, Jobs in Brussels, Data Publisher, Disclosure, Research reporting, Clinical Trial, Scientific Writing, Medical Writer, Clinical Research Writer, Medical, Project Management.

 

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Head Office Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3388
Website:  Visit Our Web Site

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