Associate Director, Regulatory Medical Writing
About the position As an Associate Director, Medical Writing, you will represent Medical Writing and provide leadership in one or more compound areas, oversees junior writers, and may assist in leading regulatory submissions. We work closely with senior Medical Writing management to help produce and ensure adherence to department guidelines, templates, standard timelines, and SOPs that follow regulatory guidelines. Responsibility will also include managing and developing staff; this may include performance management and training. Additionally, you will independently write all in-scope clinical documentation in their compound areas. This position can be either fully remote or can be on-site at our Sleepy Hollow, NY or Warren, NJ offices. A typical day may include the following: Leads all MW deliverable work for assigned compounds/indications Manages work of both internal and outsourced Medical Writers Works with clinical team to develop document strategy and write in-scope deliverables as needed Develop and articulates document strategy and timelines Identifies appropriate decision makers, focuses on results/actions. Leads regulatory submissions/submission document writing Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development Participates in new initiatives within MW and throughout Global Development Manages processes and organize priorities; solves problems; fosters collaboration to resolve conflict Leads, challenges, and develops MW team Manages and develops staff; this may include performance management, recruiting, coaching, and training Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area Remains compliant with internal training This may be for you if you: Present as a leader; is looked to for actions and decisions Can demonstrate success in managing multiple projects. Want to have an impact on patient lives. Are interested in mentoring or leading people
Responsibilities
- Leads all MW deliverable work for assigned compounds/indications
- Manages work of both internal and outsourced Medical Writers
- Works with clinical team to develop document strategy and write in-scope deliverables as needed
- Develop and articulates document strategy and timelines
- Identifies appropriate decision makers, focuses on results/actions.
- Leads regulatory submissions/submission document writing
- Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
- Participates in new initiatives within MW and throughout Global Development
- Manages processes and organize priorities; solves problems; fosters collaboration to resolve conflict
- Leads, challenges, and develops MW team
- Manages and develops staff; this may include performance management, recruiting, coaching, and training
- Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
- Remains compliant with internal training
Requirements
- To be considered a bachelor’s degree is required with an advanced degree being preferred.
- A minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement).
- Expert knowledge of the clinical research process and regulations/guidelines and regulatory writing is required.
- Expert clinical document reading, writing, and editing experience.
- Proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems.
- Thorough understanding of ICH GCP guidelines.
Nice-to-haves
- Any experience managing medical writers is helpful.
Benefits
- We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
- For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
- For other countries’ specific benefits, please speak to your recruiter.
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