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:
Acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team), generally in global mid-to late-stage development project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. The individual independently analyzes the 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 reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet Astellas corporate needs and global regulatory requirements, and provides intellectual leadership and contributes document knowledge and expertise to the global project team.
Essential Job Responsibilities:
- Acts as primary GMWRL for all assigned programs (generally mid-to-late-stage development).
- As a document specialist provides intellectual leadership and contributes document knowledge and expertise to the global project team.
- May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
- Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet Astellas corporate needs and global regulatory requirements.
- For all documents within a program, independently implements adjustments in specific document content within the framework of provided templates in order to fit the needs of specific document/core team requirements.
- Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of the time).
- May participate in a multidiscipline productivity or process initiative.
- Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data.
- 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 budget up to $3M/year per program.
- Substantially contributes to the production of high-quality documents that meet Astellas corporate needs and global regulatory requirements.
- Project tracking, program responsibility role.
- May lead a team of individuals including staff and CRO (e.g., Global Medical Writing Lead [GMWRL]; Document Working Group Facilitator [DWGF]; writer).
- BA/BS; 10+ years relevant experience. Preferred: Ph.D./Pharm D or MS/MA/MPH with at least 10 years as a writing professional in the pharmaceutical industry, with 2-5 years experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry.
- Technical expert on all document types produced by medical writing.
- Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, responses to regulatory authorities. Preferred experience in preparing for the advisory committee.
- Strong communication and leadership skills; strategic thinker
- 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
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