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Job Details

Regulatory Affairs Officer 1 - Based Reading

Company: Quintiles
Location: Reading
Reference: 1622927
Closing Date: 20 Feb 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

PURPOSE Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects. RESPONSIBILITIES • Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff. ...

Requirements:

PURPOSE

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.

RESPONSIBILITIES

Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff.

• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.

• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.

• Understands the Scope of Work, deliverables and management of budget for any given project.

• May prepare slides and background material for small, straightforward business development meetings under senior guidance and present to clients at bid defence meetings by phone or in person.

• May prepare and deliver training, as appropriate.

• Performs other tasks or assignments, as delegated by Regulatory management.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate

Good, solid interpersonal communication (oral and written) and organisation skills

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

Ability to work on several projects, with direction from senior staff as appropriate

Ability to follow SOPs consistently; provides independent thought to assist in process improvements

Ability to make decisions on discrete tasks under senior supervision

Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in life science-related discipline or professional equivalent plus 2 years relevant experience

 

Apply for this job: Regulatory Affairs Officer 1 - Based Reading

Contact Information:

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England
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