Job Details

ID #4023384
Estado Illinois
Ciudad Northchicago
Full-time
Salario USD TBD TBD
Fuente AbbVie
Showed 2020-05-28
Fecha 2020-05-29
Fecha tope 2020-07-28
Categoría Etcétera
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Senior Associate, Regulatory Affairs Submission Management

Illinois, Northchicago 00000 Northchicago USA

Vacancy caducado!

About AbbVieAbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie at https://twitter.com/abbvie on Twitter, Facebook at https://www.facebook.com/AbbVieCareers/ or LinkedIn at https://www.linkedin.com/company/abbvie/jobs .​The Senior Associate, Regulatory Affairs Submission Management, manages simple to moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams and their supervisor, the Senior Associate establishes and maintains submission planners and associated timelines, facilitates tactical submission team meetings, and represents Submission Operations on Global Regulatory Project Teams, for assigned products.

With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Participates in the development of project plans using established templates. Plans and negotiates publishing timelines with the teams.

Effectively manages multiple projects and competing priorities.

Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.

Plans and conducts submission team meetings.

Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.

Anticipates obstacles and develops solutions within the team.

Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies opportunities for efficiencies, business process improvements and cost reductions.

Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

Position accountability/scope includes some supervision of projects and assistance with priority setting required. Receives project assignments from manager but has responsibility for managing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up

Identifies opportunities for process improvements or cost savings. May participate on internal project teams to update business processes. Provides support in on-boarding new staff

Qualifications

Required Education: High School diploma or equivalent and 4 years industry related experience

Preferred Education: Bachelor’s degree. PMP and RAC certificates a plus

Required Experience: 5 years pharmaceutical or industry related experience

Experience working in a complex and matrix environment. Strong communication skills both oral and written

Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area

Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education

Significant Work ActivitiesContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)TravelNoJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Vacancy caducado!

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