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Job Details

SSU & Regulatory Specialist II (Germany)

Company: INC Research
Location: Germany
Reference: 17003325
Closing Date: 28 Aug 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life.

Requirements:

Essential Functions:

•General - Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules. Forecasts submission/approval timelines and ensures they are complied; if forecasted timelines are not reached: provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly. Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).

Responsible for one or more of the following functions at the country level:

•Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL. May serve as the primary point of contact for the SSUL/PM (or designee) during start-up on allocated projects. Reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.

•Local Site ID and Feasibility Support - Works with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from country template. Submits proposed contract and budget for site..

•Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution.

Other Responsibilities:
•Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

 

Qualifications
 

Requirements:

•BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.

•Knowledge of and a clear understanding of the overall drug development process.

• Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.

•Demonstrated clinical development and clinical research knowledge.

•Excellent verbal, interpersonal, and written communication skills.

•Good record retention and customer service skills.

• Proficient in the use of computer and software systems (e.g., Excel). Ability to successfully support internal and external customers.

•Ability to develop, organize, and manage multiple tasks. Ability to work independently.

Apply for this job: SSU & Regulatory Specialist II (Germany)

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
1126
Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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