AbbVie Associate Director, Oncology Early Development Medical Writing in United States
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 (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
Since 2013, AbbVie has expanded its commitment to the San Francisco Bay Area, now represented by three facilities in Redwood City, South San Francisco, Sunnyvale and a future new Bay Area headquarters in South San Francisco. AbbVie employees in the Bay Area drive AbbVie’s research-based, innovation driven missions in healthcare. Specifically, Bay Area employees bring deep scientific expertise and commercial excellence to advance cancer care. Current oncology areas of focus include immuno-oncology, tumor targeting, tumor dependency and precision medicine. With facilities positioned in the heart of the biotechnology industry, we are able to collaborate with the best and brightest minds in oncology.
The Associate Director, Medical Writing OED is a key role in the management, oversight, and execution of the OED portfolio. This person will be responsible for oversight and management of clinical regulatory medical writing—including management of internal and contract medical writers and oversight of CROs/vendors—ensuring successful preparation of high quality submission-ready documents and effective management of the clinical writing process. This person will provide leadership in the overall clinical regulatory document and publication strategy for OED programs, working in collaboration with the Regulatory, Clinical, and Clinical Operations teams; provide expertise in document project management for multiple compounds and/or projects within OED; and will interfaces with external groups/vendors to ensure accurate and timely completion/delivery of information and review of regulatory submissions.
Supports scientific and early development objectives for the OED portfolio in development through coordination, preparation, and approval of scientific, clinical, and regulatory documents within the Global Project Team. Projects include clinical study protocols, clinical study reports, agency briefing documents, IND annual reports, DSURs ,Investigator’s Brochures, clinical trial applications (CTA), scientific publications, and others.
Provides oversight/project management of clinical writing projects for OED portfolio, within budget and timelines. Works with Project Teams to develop project objectives, strategies, timelines, and, milestones. Effectively utilizes project management tools/techniques to drive multiple projects simultaneously. Builds cross-functional relationships and leads team meetings to address specific projects and hold team members to the deliverables.
Develops expert knowledge of international regulations, requirements, and guidelines that apply to the preparation and production of submission-ready clinical documents. Implements established standards for business purposes and ensures they are consistently applied. Ensures department understands/complies with appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs
Executes effective delegation, oversight and mentoring of permanent medical writers, contract writers, and CROs working on projects for OED.
Works directly with team members to develop/implement timelines to meet desired project completion dates. Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions. Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
Designs and implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
Serves on cross-functional task forces representing OED for development of clinical writing best practices and other initiatives.
Assists in selection and supervision of freelance consultants, CROs, and/or other vendors.
Establishes and collects appropriate metrics for OED, in collaboration with the AbbVie Medical Writing organization, that ensures a high level of internal and external writing performance as well as adherence to pharmaceutical industry standards (i.e. speed, volume, quality, complexity).
Determines resource needs within OED and manages associated budgets. Prioritizes resources to ensure efficient and timely completion of writing projects
Determines clinical writing resource needs and medical writing outsourcing strategy for oncology early development and manages both internal and outsourced personnel.
5-10 years of bio-pharmaceutical industry experience in an oncology global pharma organization, biotech company, or CRO.
A Masters, PhD or Medical Degree with strong oncology background preferred; Bachelor’s Degree and extensive previous experience working directly in the oncology, biopharmaceutical setting is also acceptable.
Minimum 3 years of project management experience, preferably with regulatory document project management and 3 or more years writing/editing and reviewing experience, preferably in the healthcare industry.
2-3 years of management/supervisory experience including employee development, or equivalent. Proven track record of managing internal and external resources. Collaborative teamwork and leadership track record.
Demonstrated high level of competency in the AbbVie leadership behaviors – All for One, Decide Smart and Sure, Agile and Accountable, Make Possibilities Real, and Clear & Courageous.
Proven effective working in a matrix environment. Excellent communication skills – easily build relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a highly matrixed organization.
Knowledge and experience with Common Technical Document (CTD) content templates. Expert knowledge of international regulations, requirements and guidance associated with document preparation and submissions.
Working knowledge of current electronic document management systems and information technology.
Significant Work Activities
Yes, 10 % of the Time
Job Level Code
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.