Astellas Pharma Senior Director Medical Writing in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose & Scope:
Provides leadership and direction for Medical Writing operations and strategy globally for all phases of drug development and life cycle management across specific focus areas, including genetic regulation . Accountable for development and delivery of documents for submission to regulatory and health authorities across the entire drug development process, ensuring high quality, clear and consistent scientific messaging in accordance with regulatory guidance for a specific therapeutic area. Provide effective management oversight for direct reports in Medical Writing roles (generally Global Medical Writing Leads [GMWrL] ) across all phases of development and both individual and summary document levels. Scope includes participation in organizational strategy, definition and maintenance of writing or QC standards and process, and allocation and management of appropriate Medical Writing resource
Essential Job Responsibilities:
Medical Writing Excellence
Participates in development of 1 -- 3 year medical writing-specific objectives and plans, and develops and implements plans to achieve objectives.
As the Medical Writing therapeutic lead, ensures development and delivery of documents for submission to regulatory and health authorities across the entire drug development process, ensuring high quality, clear and consistent scientific messaging in accordance with regulatory guidance.
Technical skill with respect to techniques of scientific writing and editing (e.g., as defined by Drug Information Association [DIA] Medical Writing Competency Model) sufficient to enable mentoring and coaching of individuals within the department or others performing Medical Writing functions.
Acts as primary GMWRL for all assigned programs (generally late-stage development). Analyzes proposed program-related, study and other documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency; ensures alignment and consistency of information and messages across all individual documents.
People Development and Leadership
Direct supervision of 5--10 core team leads (GMWRLs), including responsibility for recruitment, development / career management and retention of staff.
Coaches, develops and supports Medical Writing in providing best in class medical writing management support to Astellas drug development programs, and in effectively collaborating with other departments (internal and external) assigned to the project; generally mentoring/coaching GMWrLs, collaborations within a global project team, NDA/MAA oversight group and/or other functions within Astellas, and through CRO partnering strategies and assessments.
Provides oversight and guidance to others in completing all types of medical writing deliverables (e.g., NDA/MAA and IND/IMPD dossiers, complex briefing documents and responses to regulatory agencies) according to agreed timelines following quality standards.
Performance and Resource Management
Provides timely and accurate updates to Data Science leadership to enable successful functional support of projects.
Provides oversight of the departmental management and allocation of internal and external resources to projects, and oversees adherence to timelines, standards and processes for work performed by the department. Collaborates with therapeutic functional leads and Line Management of other functions within Medical & Development in order to ensure integrated and consistent approaches.
Collaborates with internal and external partners to ensure appropriate departmental monitoring and management of performance standards. Ensures consistency of departmental mentoring and coaching and, through collaboration with Functional Head and other function(s) within Data Science, ensures integrated and consistent Data Science approaches.
Contributes to the development and implementation of quality programs; generally evaluating and implementing recommendations for improvement within the department and supporting DS.
Reviews availability of sufficiently qualified vendor resources on a regular basis, contribute to planning of future vendor resource needs; generally through departmental resource reviews, CRO alliance and partner assessment strategies, including functional service provider forecasts.
Contributes to improvement efforts, implements agreed improvement actions and monitors effects after implementation. May lead improvement efforts with respect to departmental quality document and process standards in addition to management, mentoring and coaching activities.
Contributes to development and implementation of best in class standards, processes and SOPs in medical writing; generally, may lead or collaborate in a multidiscipline productivity or process initiative.
Responsible for Medical Writing functional support for all clinical studies and development projects globally for a specific therapeutic area, with a budget up to $15 million annually and interacting with up to 10 vendors globally.
Output includes approximately 5 Investigational New Drug applications, 5 submissions, 15 Clinical Study Reports, 20 health authority interactions and 15 Investigator Brochure updates per year.
Reports to the Executive Director of Medical Writing, with peers including Senior Director Biostatistics and Senior Director Therapeutic Area Lead Development Project Management.
Is the primary Medical Writing contact for other functional therapeutic area leads to ensure alignment on therapeutic area specific Medical & Development strategies.
Manages 5-10 GMWRLs.
As a member of the Medical Writing Leadership Team, participates in the development of Medical Writing specific strategies.
BA/BS or equivalent with 10+ years relevant experience.
Must have a successful track record in the hiring and retention of excellent medical writing professionals who work optimally in a cross functional team and matrix environment. Must have a successful track record in effectively collaborating with other functions in Development, Drug Discovery Research and Regulatory in the development and support of medicines.
Activities require sophisticated information gathering and conceptual skills, recognition and analysis of potential problems, highly complex problem solving, resourcefulness and development of policies to prevent recurrence of problems.
Strong communication and leadership skills; able to set and communicate strategy.
- PhD/Pharm D or MS/MA/MPH with 10+ years' experience as a writing, regulatory or quality professional in the pharmaceutical industry, at least 5 years' experience in activities associated with the management of regulated documents in the pharmaceutical industry, and has led/substantially participated in the Medical Writing effort for at least 2 dossiers (NDA/MAA) or has evidence of an equivalent knowledge base.
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
401(k) Match and Annual Company Contribution
Company Paid Life Insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Data Science
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans