AbbVie Associate Director, Medical Writing in Sunnyvale, California
Associate Director, Medical Writing
Location: Sunnyvale, CA
# of Openings: 1
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
Manage all aspects of document development in a fast-paced, dynamic environment
Demonstrate leadership and ownership for the development of the document from overall regulatory document strategy, review, feedback consolidation, developing resolution, and finalization of the documents
Serve as functional area lead for Medical writing in the product teams and regulatory filing submissions
Manage timelines and resources and oversee direct reports to ensure delivery of results on time, on budget and as per requirements
Key Accountabilities/Core Job Responsibilities:
Direct and oversee direct reports to ensure high quality and efficiency in the document preparation
Responsible for effective people management including understanding resource capacity, mentoring, developing, staffing and coaching of staff.
Independently write clinical study reports, clinical summaries, clinical overviews, and investigator brochures.
Manage all aspects of document development working directly with cross-functional team members: Develop and manage the timeline to support on‑time document completion, provide overall regulatory document strategy, work with Biometrics to ensure availability of statistical output that supports writing efforts, chair key message and review meetings, coordinate document audits, manage the review and approval process, and work with the publishing group as required to support their work.
Develop or revise templates, SOPs, or other guidelines for regulatory documents and lead cross-functional process improvement initiatives that lead to established standards.
Remain up-to-date on regulatory requirements/guidelines and current industry practices related to clinical regulatory writing. Implementing any changes that help drive efficiencies, reduce expenditures, eliminate redundancies and are required by the regulatory agencies.
Provides oversight/project management of clinical writing projects for assigned indication and regulatory submissions, within determined timelines. Effectively utilizing project management techniques and tools for tracking multiple writing projects.
Good understanding of experimental methods, research design, and statistical analysis
Ability to analyze medical data and interpret its significance within a pharmaceutical setting.
Ability to interpret, analyze, and present statistical data obtained in a clinical trial
Ability to effectively operate in an environment that required negotiation, collaboration, and analytical judgment
Excellent written/oral communication skills and attention to detail.
Proficient computer and word and pdf processing skills
Time and project management skills
Strong leadership in a team environment
Education and Experience:
- Bachelor's degree in a science or communication discipline with a minimum of 8 plus years medical writing experience in the regulatory, clinical or laboratory setting OR advanced degree with a minimum of 5 plus years medical writing experience in a regulatory, clinical or laboratory setting
Equal Opportunity Employer Minorities/Women/Veterans/Disabled