at AbbVie in North Chicago, Illinois, United States
Job Description
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:
Manage strategic clinical regulatory document planning efforts to fulfill objectives. Responsible for development, implementation, and maintenance of documents and/or business systems utilized for clinical regulatory document support for development teams. Address and resolve product area issues. Interface with functional groups (e.g. PK, Toxicology, Regulatory, Statistical Support, Data Management, Clinical) and writers (internal and external vendors) to ensure timely completion of projects that are scientifically accurate and of high quality. Leads clinical documents for regulatory submissions. Assists in selection and supervision of freelance consultants or other vendors.
Responsibilities:
+ Serves as Medical Writing Lead on more complex clinical regulatory documents, implementing all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and exUS).
+ Leads clinical documents for regulatory submissions. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
+ Assists in selection and supervision of freelance consultants or other vendors.
+ Accountable for meeting the main objectives of clinical writing projects in therapeutic area(s) within established timelines, budgets, and with an appropriate quality level.
+ Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, including submissions, ensuring accuracy and adherence to timelines and processes. As assigned, mentors and provides guidance to medical writers.
+ Works directly with team members to develop/implement timelines to meet desired project completion dates. Coordinates activities and communication with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, and Safety Team on writing projects/submissions. Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
+ Proficiently learns and applies therapeutic area and product knowledge to scientific projects. Develops expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of clinical documents and ensures staff understands, complies, and applies them to work products.
+ Ability to form, maintain, and lead productive cross-functional working teams, including addressing issues that arise. Collaborative teamwork and leadership track record. Implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
+ Oversees writing projects to ensure timely completion. Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.
+ Knowledgeable about the product/disease state and is an expert on clinical documents. Continually trains/be compliant with all current industry requirements as they relate to clinical regulatory submissions.
Qualifications
Qualifications:
+ Bachelor’s degree in English or Communications with relevant science expertise or Bachelor’s degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred.
+ 3 years relevant industry experience required; 5 years relevant experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D; 4 years experience in experimental design and clinical/preclinical data interpretation required; and, 2 years in a project management role required.
+ Form, maintain, and lead productive cross-functional working teams, including addressing issues that arise. Collaborative teamwork and leadership track record.
+ Working knowledge of applicable regulations and legislation.
+ Excellent business communication skills with aptitude for summarization, as well as detail orientation.
+ Experience developing and delivering presentations to senior management.
+ Ability to understand and interpret medical data and create and develop strategic messaging required.
+ Knowledge of product therapeutic area preferred.
+ Microsoft Office and Internet navigation proficiencies essential. Working knowledge of statistical concepts and techniques required. Working knowledge of other business-related information technology.
+ Identify and employ rigorous logic and methods to independently and effectively solve difficult problems within and outside routine work situations. Recognize potential scheduling and resource conflicts for project and provide recommendations to resolve. Probe multiple sources for answers. Identify hidden issues and problems beyond the obvious. Appropriately identify when to independently address the situation and when to elevate the issue to management and/or development team(s).
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
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+ 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. ?
+ This job is eligible to participate in our long-term incentive programs?
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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 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 only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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