Qureos Mentor

AbbVie

<div>Company Description 
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.
Responsibilities:<ul><li>
Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie&rsquo;s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.</li><li>
Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.</li><li>
Summarizes findings, under supervision, in concise reports for distribution within AbbVie</li><li>
Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.</li><li>
Development and guides implementation strategies for promotional activities</li><li>
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.</li><li>
Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members</li><li>
Effectively presents pertinent information to appropriate cross-functional groups.</li><li>
Effectively delivers difficult messages to commercial organizations without damage to relationships</li><li>
Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.</li><li>
This role will work a hybrid work schedule (3 days in office &amp; 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA; Washington, D.C.; or Rockville, MD.</li></ul>
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required 
Qualifications 
<ul><li>
Minimum: Bachelor&rsquo;s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)</li><li>
Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)</li><li>
Experience working in a complex and matrix environment and exhibits strong negotiation skills</li><li>
Strong communication skills, both oral and written</li><li>
Experience in management capacity preferred</li><li>
Experience in US Regulatory Affairs Advertising and Promotion</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our long-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.
<div></div>AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

<div>Company Description 
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
This role is field-based and candidates should live within a reasonable distance from the primary city. Talent will be hired at a level commensurate with experience.
Execute brand strategy and tactics in field, sales performance, effectively manage assigned territory and targeted accounts, build strong customer relationships and customer needs solving capability to maximize short and long term sales performance placing the patient into the center of any efforts and operating within AbbVie&rsquo;s business code of conduct, policies and all applicable laws and regulations.
Responsibilities<ul><li>
Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. in order to meet or exceed on those objectives.</li><li>
Create pre-call plan using SMART objectives and execute post-call evaluation in order to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action in order to close on every sales call.</li><li>
Proactively and continuously aspire to serve customer needs, customer expectations and challenges in order to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers.</li><li>
Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers in order to maximize access and sales opportunities.</li><li>
Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution.</li><li>
Differentiate AbbVie&rsquo;s value proposition with health providers assigned and identify, develop and maintain disease state experts and speakers/advocates in order to maximize brand performance.</li></ul> 

Qualifications 
<ul><li>
Bachelor&rsquo;s degree in health, sciences, pharmacy or business-related field preferred or relevant and equivalent industry experience required</li><li>
Relevant and equivalent industry experience required in lieu of a bachelor&rsquo;s degree is at least five (5) years of experience with three (3) or more years of experience within the pharmaceutical/health/science industry preferred and a high school diploma/GED required</li><li>
Proactively identifies customer style / behavior and adapts quickly all aspects of selling approach.</li><li>
Proven track record of success in selling and solid presentation skills. Offers innovative ideas and solutions to maximize business opportunities to address challenges. Understands and leverages findings to develop sales strategies.</li><li>
Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities. Operates effectively in a matrix environment. Provides impact with ideas for the larger organization and anticipates and responds to changes.</li><li>
Influences others &amp; is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc. Leads by example; Consistently displays positive behaviors and peer coaching through changing and challenging environments.</li><li>
Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels.</li><li>
Preferred: Proven track record of success in sales performance within respective therapeutic areas. Commercial pharmaceutical industry experiences such as physician/account based selling, training, managed health care or marketing preferred. English language proficiency verbally and in writing (for all non-English speaking countries).</li><li>
Valid driver&rsquo;s license: Ability to pass a pre-employment drug screening test and meet safe driving requirements</li><li>
Ability to travel adequately to cover territory, as well as overnight attendance at scheduled training events and sales meetings</li><li>
Driving a personal auto or company car or truck, or a powered piece of material handling equipment</li><li>
An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials.</li><li>
These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.
<div></div>AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Specialty Representative, GI Care - Orlando South, FL

<div>
 
 Company Description
 
 
 
 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 &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
 
 
 
 Job Description
 
 
 
 The Associate Director, Third Party Manufacturing (TPM) Manager will be the main supplier relationship contact person in charge of providing the organization, supervision, strategic initiatives, and technical support necessary to manage supply of designated products. The role will ensure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. This position also manages projects and programs impacting AbbVie to ensure a cost effective, marketable and manufacturable product and maximizes profitability throughout its life cycle. Through matrix management of cross functional groups/individuals, the Associate Director, TPM is responsible for leading various teams without direct authority, providing program management support, and is the primary AbbVie representative to coordinate operations for existing and new products manufactured with the supplier.
 
 
 
 Responsibilities
 
 :
 
 
 <ul>
 <li>
 Participate in the negotiation of the Manufacturing Service Agreement and amendments, and ensure compliance with the terms of the agreements.
 </li>
 <li>
 Ensure effective planning and material procurement strategies are in place to supply the TPM with the required materials.
 </li>
 <li>
 Communicate to the TPM the product forecasts, and agree on manufacturing and delivery schedules. In coordination with Supply Chain and Planning, ensure the supplier delivers the product according to the demand forecasted.
 </li>
 <li>
 Actively participate in the development of Financial Operating Plan, Updates, LRP, and Standard processes, and ensure the financial goals are met
 </li>
 <li>
 Coordinate the Steering Committee and monitor that the Virtual Operation Teams meet periodically to evaluate performance, address issues, and if necessary escalate.
 </li>
 <li>
 Review status reports and prepare updates for Senior leadership.
 </li>
 <li>
 In collaboration with technical and quality teams, periodically review process performance, quality trends, and agree on process improvement plans.
 </li>
 <li>
 Establish governance, guidelines, and communication channels. Ensure in coordination with the quality units that the supplier has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments.
 </li>
 <li>
 Coordinate with QA, the annual quality management review and periodic audits of the TPM. Ensure deviations are properly investigated and product disposition decisions are made in a timely manner. Establish performance metrics and periodically track performance.
 </li>
 <li>
 Develop, implement and manage the programs or projects such as scope, cost, time &amp; resource management, communication and risk management through the initiating, planning and executing phases of the project.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree, preferably in science or technical related field. MSc or MBA degree is preferred.
 </li>
 <li>
 A minimum of 10+ years of experience, in areas such as: manufacturing, engineering, project management, quality and S&amp;T.
 </li>
 <li>
 The individual needs a broad business perspective, knowledge and understanding of manufacturing processes.
 </li>
 <li>
 Strong project experience and an ability to influence others are essential.
 </li>
 <li>
 Previous experience managing subcontracted relationships preferred.
 </li>
 <li>
 Proven leadership ability with superior communication skills including listening, verbal, presentation and written.
 </li>
 <li>
 Strong strategy development and planning skills coupled with necessary knowledge of pharmaceutical development, manufacturing and supply activities.
 </li>
 <li>
 Issue identification and strong problem analysis and solution development skills.
 </li>
 <li>
 Demonstrated team player and ability to work in a globally oriented work environment.
 </li>
 <li>
 Strong knowledge of business financial systems and tools
 
 
 </li>
 </ul>
 Additional Information
 
 
 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
 
 
 <ul>
 <li>
 The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
 </li>
 <li>
 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
 </li>
 <li>
 This job is eligible to participate in our short-term incentive programs.
 </li>
 <li>
 This job is eligible to participate in our long-term incentive programs
 
 
 </li>
 </ul>
 Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Associate Director, External Manufacturing - Small Molecule

<div>
 
 Company Description
 
 
 
 
 About AbbVie
 
 
 
 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
 
 
 
 Job Description
 
 
 
 
 These positions are field based / remote in the following locations: CA, WA, OR, IA, MN, IN, OH, FL. Candidates must reside in one of the these states and be willing to travel for site visits.
 
 
 
 
 Purpose
 
 
 
 Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
 
 
 Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
 
 
 Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.
 </li>
 <li>
 Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
 </li>
 <li>
 Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
 </li>
 <li>
 Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
 </li>
 <li>
 Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
 </li>
 <li>
 Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
 </li>
 <li>
 Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
 </li>
 <li>
 Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
 </li>
 <li>
 Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
 </li>
 <li>
 Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
 </li>
 <li>
 Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk&hyphen;based monitoring approach, onsite and offsite monitoring.
 </li>
 <li>
 Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
 </li>
 <li>
 Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
 </li>
 <li>
 Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
 </li>
 <li>
 Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
 </li>
 <li>
 Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
 </li>
 <li>
 Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
 </li>
 <li>
 Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
 </li>
 <li>
 Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
 
 
 </li>
 </ul>
 Additional Information
 
 
 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
 
 
 <ul>
 <li>
 The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
 </li>
 <li>
 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
 </li>
 <li>
 This job is eligible to participate in our short-term incentive programs.
 
 
 </li>
 </ul>
 Note: No amount of pay is considered to be wages 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 benefits that are allocable to aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

<div>Company Description 
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas, both through individual contribution and through the work of staff. The Associate Director provides training and performance management for staff. The Associate Director demonstrates leadership competencies, builds relationships, and promotes teamwork within the Statistical Programming organization and across functions. The Associate Director is accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. The Associate Director makes key recommendations and decisions related to processes, standards, and resource management. The Associate Director is also responsible for staff management and development.
Responsibilities:<ul><li>
SAS Programming: Demonstrates a strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry and applies that knowledge to resolve non-routine problems.</li><li>
Standards: Oversees the development and implementation of global company standards for output design and programming conventions and monitors regulatory guidance and industry best practices.</li><li>
CRFs and Database Definitions: Provides strategic guidance on CRF and database design and reviews global standards related to these deliverables.</li><li>
Derivation Programming, Submission Data Sets, and Programs: Interprets statistical analysis plans, develops analysis data set specifications, and oversees the development and implementation of global standards for derived data sets and submission programs.</li><li>
Cross-Functional Collaboration: Works collaboratively with stakeholders to manage priorities and resources across therapeutic areas. Demonstrates a solid understanding of drug development principles, anticipates risks, develops contingency and escalation plans, and contributes to cross-functional initiatives.</li><li>
Communication: Presents statistical programming concepts, risk assessments, and recommendations clearly and persuasively to statisticians, scientists, programmers, and non-scientists. Effectively leads meetings and presentations.</li><li>
Training and Mentoring: Provides guidance, training, and mentoring to staff to support development and ensure compliance with training requirements.</li><li>
Staff Management: Assigns responsibilities, defines scope, and reviews progress to ensure projects are delivered on time and with appropriate quality. Allocates resources to maintain the right balance of expertise across projects and collaborates with management to assess staffing needs. Sets high expectations, promotes open communication, and leads staff to meet organizational goals. Provides performance management for 4&ndash;10 statistical programmers.</li></ul> 

Qualifications 
Minimum Qualifications:<ul><li>
Degree in Statistics, Computer Science, or a related field</li><li>
10+ years of statistical programming experience (with MS) OR 12+ years of statistical programming experience (with BS)</li><li>
Strong technical competence in SAS programming and macro development.</li><li>
Experience in pharmaceutical clinical trials.</li><li>
Experience with regulatory filings such as NDA, BLA, or other submissions, including ISS and ISE experience.</li></ul>
Preferred Qualifications:<ul><li>
Experience interacting with regulatory agencies, especially FDA and EMEA.</li><li>
Previous management experience.</li></ul>
Other Required Skills:<ul><li>
Working knowledge of ICH guidelines and relevant regulatory requirements.</li><li>
Strong oral and written communication skills.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our long-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Associate Director - Statistical Programming (Hybrid)

Join AbbVie and explore 11   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

AbbVie

About Company

Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

Specialty Representative, GI Care - Orlando South, FL

Associate Director, External Manufacturing - Small Molecule

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Associate Director - Statistical Programming (Hybrid)

Associate Director - Statistical Programming (Hybrid)

Associate Director - Statistical Programming (Hybrid)