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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.

Senior Manager, Medical Writing

Req ID 2207772 Category Clinical Research Division AbbVie

Responsible for development, implementation, and maintenance of documents and/or business systems utilized for clinical regulatory document support for development teams. Manage strategic clinical regulatory document planning efforts to fulfill objectives. Leads  writing of clinical documents for regulatory submissions.  Assists in selection and supervision of freelance consultants or other vendors. 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.

Responsibilities:

•Serves as Medical Writing Lead on complex Oncology Early Development (OED) 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, including Investigator Brochures (IB), Protocols, DSURs, and Clinical Study Reports (CSR). 
•Assists in selection and supervision of freelance consultants or other vendors. Recognizes potential scheduling and resource conflicts for projects across assignments and provides recommendations to resolve.
•Accountable for meeting the main objectives of clinical writing projects inOncology Early Development within established timelines, budgets, and with an appropriate quality level.
•Provides project management or may oversee a project manager for writing projects for multiple compounds and/or indications within OED, 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/writing teams, including addressing issues that arise and effectively leading document adjudication with multiple stakeholders. 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:

•Bachelor's degree in English or Communications with relevant science expertise or Bachelor's degree in Life Science with relevant writing expertise.  Advanced degree (doctorate) highly preferred. 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).

Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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