Astellas Pharma Medical Writing Program Director in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.Astellas is announcing a Medical Writing Program Director opportunity in Northbrook, IL.
Purpose & Scope of Position:
The individual acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team) in late-stage development project teams. The individual provides leadership with respect to program documents and particularly will lead the writing activities for IND/IMPD and NDA/MAA dossier components, briefing documents, and responses to regulatory authorities and may act as a NDA/MAA expert across all programs. The individual analyzes proposed program, study and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual ensures a consistent pattern of successful completion of assigned program responsibilities through strategic problem-solving and the ability to marshal resources in a productive and efficient manner in order to produce high quality documents that meet Astellas corporate needs and global regulatory requirements. The individual provides intellectual leadership and contributes document knowledge and expertise to the global project team. The individual may be responsible for overall project document management within medical writing, ensuring effective, high quality and timely departmental output. The individual may lead a multidiscipline productivity or process initiative and drives efforts to ensure processes remain aligned with best practices and corporate needs.
Essential Job Responsibilities:
- 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.
- Defines, develops and implements GMWRL strategies and plans to accomplish global project objectives.
- As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
- Collaborates with the program's global leads for development operations (GDOL), medical sciences (GML), and statistics (GSTATL) to ensure integrated and consistent Global Development Operations' approaches and performance within the program.
- Collaborates with internal and external stakeholders.
- Provides timely and accurate updates to GDO leadership during project review to enable successful functional support of projects.
- Works closely with Line Management to ensure successful management of vendors.
- Assists the Functional Management Head or more senior management in ensuring a consistent pattern of successful completion of assigned departmental responsibilities.
- May be responsible for overall project document activities within Medical Writing, ensuring effective, high quality and timely departmental output; may act as a NDA/MAA expert across all programs.
- May lead a multidiscipline productivity or process initiative.
- Drives efforts to ensure processes remain aligned with best practices and corporate needs.
- Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 20% of time).
- Contributes to the quality and performance of Contract Research Organization (CRO) and staff, impacting costs and program success.
- Directly or indirectly responsible for oversight of Medical Writing activities, through CRO alliances and performance management, with budgets up to $4-6M/year per program.
- Able to foster adherence to the departmental mission.
- Able to optimize the efficiency of the department and maintain positive and collaborative relationships with other departments, other members of project teams, and globally.
- Project track, program responsibility role.
- May lead a team of individuals including staff and CRO (CRO Global Medical Writing Lead [GMWRL]; Document.
- Working Group Facilitator [DWGF]; writer).
- BA/BS; 10+ year's relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as writing professional in pharmaceutical industry, with 5 years' experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry and having led the Medical Writing effort for at least 2 dossiers (NDA/MAA) or has evidence of an equivalent knowledge base. Preferred experience with advisory committee(s).
- Able to take a leading role in development of global standards and on global task forces.
- Demonstrated and substantial experience in leading the creation of IND/IMPD and NDA/MAA components, briefing documents, and responses to regulatory authorities.
- Activities require advanced 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 strategy.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Global Development Operations