AbbVie
Senior Scientist, I
AbbVie, North Chicago, Illinois, us, 60086
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onTwitter ,Facebook ,Instagram ,YouTube andLinkedIn .Job Description
Candidate will participate in global regulatory dossier preparation activities by coordinating cross-functional data gathering from teams of subject matter experts, from internal and external third parties. The primary function is to prepare drug substance, drug product and analytical sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, efficient processes for preparation of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy.Responsibilities:Author CMC submission documentation for all phases of clinical development, often under significant time pressure.Author internal documentation of manufacturing control strategies to support CMC submission documentation.Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrate strong negotiating, influencing, and leadership skills.Manages completion of CMC regulatory submission documentation for multiple projects of moderate complexity utilizing a matrix management approach. Individually completes submission document authoring, and implements other creative approaches to conserve resources, and achieve efficiency with respect to time and budget.Develop an organizational memory of regulatory issues. Review regulatory guidance documents to develop and maintain expertise. Coordinate authoring and reviews across CMC functions.Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.Qualifications
Bachelor’s Degree with at least 8 years of CMC functional experience; Master’s Degree with at least 6 years of CMC functional experience or PhD Degree with at least 2 years of CMC functional experience.Excellent scientific writing skills and working knowledge of regulatory requirements.Excellent communication skills, written and verbal, with a demonstrated ability to summarize and communicate findings in a timely and efficient manner.Demonstrated ability to make decisions based on scientific data, to manage and prioritize multiple projects simultaneously, and to work with a sense of urgency.Demonstrated skills in negotiation, influencing others, and leadership.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs.Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Candidate will participate in global regulatory dossier preparation activities by coordinating cross-functional data gathering from teams of subject matter experts, from internal and external third parties. The primary function is to prepare drug substance, drug product and analytical sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, efficient processes for preparation of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy.Responsibilities:Author CMC submission documentation for all phases of clinical development, often under significant time pressure.Author internal documentation of manufacturing control strategies to support CMC submission documentation.Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrate strong negotiating, influencing, and leadership skills.Manages completion of CMC regulatory submission documentation for multiple projects of moderate complexity utilizing a matrix management approach. Individually completes submission document authoring, and implements other creative approaches to conserve resources, and achieve efficiency with respect to time and budget.Develop an organizational memory of regulatory issues. Review regulatory guidance documents to develop and maintain expertise. Coordinate authoring and reviews across CMC functions.Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.Qualifications
Bachelor’s Degree with at least 8 years of CMC functional experience; Master’s Degree with at least 6 years of CMC functional experience or PhD Degree with at least 2 years of CMC functional experience.Excellent scientific writing skills and working knowledge of regulatory requirements.Excellent communication skills, written and verbal, with a demonstrated ability to summarize and communicate findings in a timely and efficient manner.Demonstrated ability to make decisions based on scientific data, to manage and prioritize multiple projects simultaneously, and to work with a sense of urgency.Demonstrated skills in negotiation, influencing others, and leadership.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs.Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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