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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose: Proficiently manage the nonclinical portion of regulatory submissions involving multiple cross-functional subject matter experts. With input from the submission teams and project representatives, this individual establishes and maintains the nonclinical (Module 4) submission content planner, associated documents and timelines in support of development, marketing, and post-marketing regulatory authority applications.

Responsibilities:

• Oversee nonclinical submission content, ensuring the timely delivery of high-quality dossier components that align with technical specifications outlined by regulatory authorities. These components should facilitate easy navigation and review by regulatory agencies. Serve as a liaison with scientific Subject Matter Experts (SMEs), conveying established submission processes and standards.
• Coordinate and manage multiple interrelated activities concurrently for submission projects or various reports. Proactively anticipate obstacles and collaborate with the team to formulate solutions. Facilitate the creation or procurement of submission content deliverables such as summary documents, reports, and literature references.
• Conduct thorough quality assessments of published output, ensuring alignment with regulatory standards and health authority guidance. Verify content, including Study Tagging Files and SEND components (where applicable), bookmarks, hyperlinks and tables of content.
• Contribute to the development of optimal business processes and standards within the department, ensuring robust stakeholder support to achieve high quality submissions. Play a role in crafting and implementing internal standards for submission documents.
• Position accountability/scope:
  • Regularly engage with the manager to discuss project priorities, timelines, progress and identified challenges.
  • Manage projects with oversight as necessary.
  • Provide training and cross-train with other team members to offer additional support as required.

Qualifications

Education/Experience:

• Bachelor’s Degree, or equivalent education.
• Theoretical and practical knowledge to carry out job functions.

Preferred:

• Experience supporting nonclinical research and development in the pharmaceutical industry preferred.
• Experience with GLP or related regulatory environments.

Competencies:

• Adaptability in handling a changing workload, effectively prioritizing and planning to address both immediate/urgent business needs and long-term objectives. Strong collaboration and teamwork skills essential for interactions within small teams and external business communications.
• Understanding of toxicology or related nonclinical study design and conduct as it relates to data in submission package.
• Ability to work independently while contributing constructively as a collaborative team member.
• Resolution oriented- uses reasoning to troubleshoot and provide possible solutions to issues regardless of origin, relentlessly seeks root cause of issues.
• Proficient in swiftly acquiring relevant background information, consulting subject matter experts and management, and offering solution proposals.
• Skilled in working with computer systems and software.
• Approach tasks with a proactive mindset, formulating and communicating action plans and potential issues. Capable of delivering services and results punctually, accurately, and in line with expectations.
• Consistently exhibit excellent communication skills, both written and verbal, capable of conveying complex technical matters clearly.
• Willingness to challenge the status quo.
• Detail-oriented while grasping and addressing the broader context.
• Must demonstrate and consistently use excellent interpersonal skills.
• Ability to integrate and retain new information quickly.
• Proficient as a change agent, adept in managing system upgrades and migrations, enhancing business processes, and effectively managing priorities.

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 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.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

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’s sole and absolute discretion, consistent with applicable law. ​

AbbVie 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.

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.