Senior Manager of Medical Writing, Regulatory Strategic Writing
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 Medical Writing for Regulatory Strategic Writing (RSW) is responsible for leading one or more writing teams for corresponding compound programs within a Therapeutic Area (TA) (eg Oncology, Immunology or Specialty Products). The Senior Manager role is instrumental in the supervision of resources (internal or external) and providing writing assistance in a team’s efforts to support critical regulatory submissions and responses to health authority requests and questions. In partnership with the Global Regulatory Product Team (GRPT), the RSW team drives the compilation and preparation of critical global strategic regulatory submission documents comprised of strategic, high-quality scientific justification of company positions and relevant knowledge for submission to global health authorities. The Senior Manager role reports to a TA Associate Director or Director within RSW.
- In cooperation with Global and Area Regulatory Leads and functional area contributors, coordinate assigned program(s) and projects necessary to support TA interactions with healthcare authorities. Collaborate effectively with the Global Regulatory Project Team (GRPT) and Global Project Teams (GPT) including functional area contributors (eg, Clinical, Pharmacovigilance, CPPM, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science.
- Provide regulatory writing expertise, leadership, project management, and supervision of RSW resources. Provide strategic input for assigned compounds and/or projects. Ensure delivery of submission-ready documents for incorporation into the final submission.
- Promote active and continuing growth as a program subject matter expert for self and all RSW contributors, including expert knowledge of relevant healthcare authority guidelines and regulations, as well as all relevant AbbVie regulations, guidelines, and SOPs. This expertise extends to all techniques and procedures necessary to contribute to the strategic vision and the execution of all medical writing and program objectives.
- Provide strategic input with respect to the selection of candidates and decision making in the hiring, on-boarding, training, and supervision of full-time staff and external resources supporting RSW programs and initiatives. Contribute to performance review activities for the team members by providing feedback to the TA Lead.
- Supervise RSW contributors on assigned regulatory document support requests (internal or external resources). Provide writing support and document drafting as needed. Track required deliverables and communicate timeline/milestone progress to team members. Interface with internal and external groups to ensure accurate and timely completion/delivery of information to be submitted.
- Coordinate timelines and processes for preparation, review, QC, approval, and other appropriate functions involved in the production of regulatory submissions assigned in conjunction with appropriate RSW resources and project planning resources.
- Ensure active maintenance of assigned projects in the RSW Book of Work either by personal contribution or through supervision of assigned resources. Assist forecast of workload for assigned TA.
- Provide mentorship for internal or external resources assigned to projects within the Senior Manager’s remit. Provide feedback to TA Lead with respect to individual contributions for use in performance reviews per the judgment of the TA Lead.
- A Bachelor’s degree is required. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is 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 5 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
- Minimum of 4 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
- Excellent business communication skills with aptitude for summarization, as well as detail orientation. Experience with providing concise project summaries and program presentations to senior staff.
- Proven ability to identify issues and employ rigorous logic and methods to independently and effectively solve difficult problems within and outside routine work situations.
- Strong leadership skillset with an aptitude for high functioning collaboration in ambiguous or difficult situations. Ability to determine when to resolve issues independently or elevate to next level management.
- RA management
- Global Regulatory Product Team members and their associated Regulatory Leads
- R&D functional management and members involved in generating regulatory submission documents
Function: Regulatory Affairs
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.