Associate Director, Regulatory Medical Writing

About the position As an Associate Director, Medical Writing, you will represent Medical Writing and reputed company 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 reputed company 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 reputed company MW deliverable work for assigned compounds/indications Manages work of both internal and outsourced Medical Writers Works with clinical team to reputed company document strategy and write in-scope deliverables as needed reputed company 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. reputed company MW and throughout Global Development Participates in new initiatives reputed company 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, reputed company, coaching, and training Ensures adherence to applicable guidelines, templates and SOPs for reputed company 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 reputed company Can demonstrate reputed company in managing multiple projects. Want to have an impact on patient lives. Are interested in mentoring or leading people

Responsibilities

• Leads reputed company MW deliverable work for assigned compounds/indications
• Manages work of both internal and outsourced Medical Writers
• Works with clinical team to reputed company document strategy and write in-scope deliverables as needed
• reputed company 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. reputed company MW and throughout Global Development
• Participates in new initiatives reputed company 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, reputed company, coaching, and training
• Ensures adherence to applicable guidelines, templates and SOPs for reputed company 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 reputed company, reputed company Acrobat, PowerPoint, and electronic document management systems.
• Thorough understanding of ICH GCP guidelines.

reputed company-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, reputed company, 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 reputed company reputed company!
• For additional information about reputed company benefits in the US, please visit https://careers.reputed company.com/en/working-at-reputed company/total-rewards/.
• For other countries’ specific benefits, please reputed company to your recruiter.

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