Senior Manager of Medical Writing (Oncology)

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 .

The Senior Manager of Medical Writing manages 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

• Bachelors degree in English or Communications with relevant science expertise or Bachelors 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).

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.