Senior Associate, Clinical Trial Disclosure

About AbbVie
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. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

• Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
• Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
• Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
• Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
• Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results disclosure public postings.
• Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
• Identifies conflicts and resolves or elevates them to management to ensure resolution.
• Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
• Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
• Continually trains/is compliant with all current industry requirements as they relate to clinical trial disclosure and various regulated agencies.

Qualifications

• Bachelor's degree or equivalent relevant experience is required preferably in nursing, pharmacy or scientific field.
• Must have 3 years of clinical research experience or experience in a related area such as quality, regulatory, compliance, clinical research, or drug development.
• 2-3 years relevant industry experience in medical writing in the healthcare industry or academia preferred; American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
• Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required. Relationship management, communication ability, influencing skills required.
• Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
• Working knowledge of US and international regulations requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
• Working knowledge of current electronic document management systems and information technology. Proficient with major Microsoft suite programs.
• Ability to assimilate and interpret scientific content and translate information for appropriate audience.
• Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At 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.