Regulatory Data Management (RDM) Team Lead, Center of Excellence, GRPD, Poznan
GlaxoSmithKline 1 118 ocen - Poznań, wielkopolskie
Basic qualifications:

• min. 3 years of experience in regulatory affairs or in complex technical environment,
• capability to build and maintain a team,
• bachelors degree in scientific or technical field,
• fluent Polish and English (both verbal and written),
• strong interpersonal and communication skills,
• customer-focus and service orientation,
• competency in the use of data management tools and sound understanding of the procedures and standards,
• ability to perform multiple tasks, set the right priorities to deliver objectives on time,
• adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.

Preferred qualifications:

• well developed leadership skills,
• negotiation, problem solving and innovation skills,
• practical knowledge of risk management,
• successful delivery of complex projects or project team leadership,
• Project Management experience would be an asset.

Details:

GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.
Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

RDM Team Lead will report to Submissions Delivery Manager and will be accountable for maintaining GSK product registration information to a standard appropriate to support critical regulated processes to ensure patient safety, regulatory compliance and effective business operations. RDM Team Lead will be accountable for quality and accuracy of own and team assignments and interfacing with the large number of customers across GSK.

In your new role as the RDM Team Lead you will:

• manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment;
• advise, train and support users of the RIM (Regulatory Information Management) system and procedures;
• deal with more complex and non – routine data maintenance tasks;
• maintain knowledge of GSK standards and procedures associated with registration data management and contributing to the definition of new and revised procedures to improve quality and effectiveness;
• act as quality control point;
• identify risks to quality and/or timely completion of projects, resolving any issues and escalating items to be resolved at a higher management level;
• drive continuous process improvement within areas of your influence;
• monitor regulatory intelligence and act proactively on identified changes to regulatory requirements;
• build and maintain quality relations with your internal and external stakeholders;
• work closely with your peers and manager to drive standardization across the business.

Closing date for applications: 10th April 2016.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

Contact information:

You may apply for this position online by selecting the Apply now button.

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GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...