Job Description

Duration: 12 Months Contract (Possible Extension)

***NOTE - This is mostly remote, initial week to be expected onsite, after that the candidates expected to only come for meetings.***

Requirements -

• Technical Writing
• Pharmaceutical or Related industry (Preferred Pharma)
• Flexible working hours between 20 - 30 hours/ per week
• Preferred to come on site 1 - 2 times per month

Duties:

• Provides general administrative support to one or more managers.
• Responsibilities include: Exercises discretion in handling of confidential material and information. Assists in special projects as assigned. Responsible for organization and maintenance of department filing system including potentially confidential data. May provide clerical support as necessary, including filing, etc. Completes other duties as requested.
• Act as the BIRDS LBAC for the group, act as first point of contact to support training and business issues for problem solving for the BIRDS (BI Regulatory Documents System) system.
• Inform the group of new developments in BIRDS, current updates and relevant information. Work closely with the DRA Manager of the EU Regional Archiving Center to discuss and develop workarounds and best practices for the archiving process. Communicate with other Key Users and LBACs to exchange pertinent information as the new BIRDS system roles out and evolves into the Human Pharma community. Elevate unsolvable problems to the next business level GBAs (Global Business Administrator) and the Business Support Team as necessary.
• Documentum (IDEA for SUB) Key User
• Provide detailed guidance for authors too successfully archive Non-Clinical & Technical reports through a series of highly regulated stages required by DRA & the FDA. Coordinate this process with authors & the DRA Group to move the reports through the various stages & final signing & archiving. Act as liaison with DRA, IDEA for SUB Americas & Germany, to assist users with new procedures & available training.
• Act as liaison for new Regulatory Documents for Submissions (BIRDS) system that is currently replacing IDEA for Sub.

Skills: Technical Writing Experience.

Education:

BS Required.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Name: Kanika Dureja

Email: [email protected]

Internal Id: 25-33773

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