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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.

Director Medical Writing Oncology Early Development - Remote

Primary South San Francisco, California Secondary Remote Req ID 2213370 Category Research and Development Division AbbVie

 

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.  AbbVie is expanding its oncology early development pipeline.  More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, 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.  

The Director, Medical Writing and Operations is a key role in the management, oversight, and execution of the OED portfolio. This person will be responsible for establishing and leading the medical writing team, including medical writing operations (e.g., Medical Writing Coordinating/Report Publishing and Documentation Specialists, Quality Control, and/or Word Processing & Standards) within Oncology Early Development (OED)—including management of internal and contract medical writers and oversight of CROs/vendors. This person will be accountable for 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, Safety, Clinical, Data Management, and Clinical Operations teams; provide expertise in document project management across the OED portfolio; determine resource needs and develop tactical plans to execute outsourcing strategy and manage expectations with vendors and internal staff; and will interface with external groups/vendors to ensure accurate and timely completion/delivery of information and review of documents for regulatory submissions.

 

 

 

 

Responsibilities:

  • Directs centralized medical writing team across programs in OED, ensuring successful preparation of high-quality, submission-ready documents, and effective management of the clinical writing process in accordance with clinical and regulatory timelines, including oversight of CRO medical writing processes and documents. 
  • Provides strategic oversight and sets vision for OED Medical Writing and Operations team, including resources, business processes, budget, metrics, compliance, and systems. Determines resource needs within OED medical writing and operations and manages associated budgets.  Prioritizes both internal and external (e.g., vendor, CRO) resources to ensure efficient and timely completion of writing projects.
  • Executes effective delegation, oversight, direct line management, and mentoring of personnel located in geographically dispersed locations.  Leads selection and supervision of freelance consultants or other vendors.
  • Develops standards for working with vendors that ensure effective management of vendors. Supports scientific and development objectives for OED portfolio through coordination, preparation, and approval of clinical, scientific, and regulatory documents.
  • Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project management for several projects simultaneously. Designs and implements systems and creative solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
  • Works with cross-functional project teams to develop project objectives, strategies, corresponding timelines, and milestones.  Coordinates activities and communications with cross-functional areas on writing projects/submissions utilizing cross-functional skills/expertise and drug development knowledge.  Builds cross-functional relationships/leads team meetings to address specific projects and hold team members to the project tasks/deliverables.
  • Develops and applies expert knowledge of international regulations, requirements, and guidelines that apply to the preparation and production of submission-ready clinical documents. Implements established standards and work processes, as appropriate to ensure they are understood and consistently applied.  .
  • Establishes and collects appropriate metrics across OED, 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).        
  • Serve as primary medical writer for high-priority projects with OED. Projects include clinical study protocols, clinical study reports, agency briefing documents, IND annual reports, DSURs, Investigator’s Brochures, clinical trial applications (CTA), briefing books, scientific publications, and OED document processes (eg, SOPs, work practices, job aides, templates and other supportive documentation, etc.) as needed, to align with department and organizational goals, to stay compliant with corporate guidelines, and to leverage current IT platforms efficiently.
  • Establishes strategy and leads team to effectively transition projects to medical writing team responsible for late-stage assets, as assets progress through development.
  • Ensure a consistent approach to real-time inspection readiness by providing leadership as SME.  Ensure maintenance of documentation in preparation and in support of audits/inspections.  Facilitate/lead the MW inspection readiness activities to ensure end-to-end audit/inspection readiness at all times, including inspection support (e.g., responsibility to provide input into/quality check responses to observations/reports).

Qualifications:

•A Bachelor’s degree is required. A relevant advanced degree (e.g. MS, Pharm D, PhD, MD) is strongly preferred, and higher education may compensate for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.

•Minimum of 3-5 years oncology experience

•Minimum 5-10 years relevant industry experience in medical/regulatory writing in the pharmaceutical industry (e.g., sponsor, biotech, CRO), including experience regulatory briefing packages, writing clinical protocols, Investigator Brochures, Drug Safety Update Reports (DSUR), and Clinical Study Reports (CSR).

•Requires problem solving abilities at both strategic and operation levels.  Must be comfortable operating within “gray,” with a high tolerance for ambiguity, reaching decisions with limited information.  Must exercise strong judgment in distinguishing issues needing elevation, as well as the level to which an issue should be elevated.  Challenges and make recommendations to the Head of OED Clinical Operations to achieve best possible timeline and resource utilization.

•Minimum 3-5 years of project management experience, preferably with regulatory document project management and 3 or more years writing/editing and reviewing experience, preferably in the pharmaceutical/healthcare industry.

•Minimum 3-5 years of management/supervisory experience including employee development and management of external resources, including developing and motivating direct reports and addressing performance issues.

•Knowledge and experience with Common Technical Document (CTD) content templates including regulatory submission experience.  Expert knowledge of international regulations, requirements, guidance, and effective processes associated with document preparation and submissions, including proven ability to create strategic, division-wide documents and writing plans.  Working knowledge of current electronic document management systems and information technology.

•Demonstrated abilities in leadership and teamwork capacities managing projects for multiple compounds, therapeutic areas (both large and small), and regulatory submissions using both internal (multidisciplinary) and external resources, many of which are geographically dispersed, using project management tools and processes for on time delivery of quality products.

•Experience in financial resource management.

•Experience recognizing and resolving potential scheduling and resource conflicts for project and provides recommendations to resolve. 

•Experience leading process improvement initiatives, both within the department and division-wide.

•Demonstrated experience in collaborating cross functionally; needs minimal guidance on forging strategy and executing on that strategy. Able to increase the level of skill of team over time. Strong written and verbal communication skills, including strong negotiation skills. Comfortable with challenging status quo and making recommendations to advance OED objectives and achieve best possible solutions..

•Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required.  Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA).


At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


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

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