Director Medical Writing & Outsourcing

Company: Regeneron Pharmaceuticals
Location: Tarrytown
Posted on: June 10, 2021

Job Description:

The Director of Medical Writing & Outsourcing will be responsible for the management and development of outsourced writing activities within the Medical Writing department. The Director will work with senior members of the Medical Writing staff to help produce department guidelines, templates, standard timelines and SOPs that follow regulatory guidelines. They will be responsible for ensuring adherence to said guidelines templates, timelines, and SOPs for all Medical Writing documents, and will be responsible for the management and development of external staff, including all training and onboarding for all writers.

In this role, a typical day might include the following:

Development and ongoing optimization of outsourcing strategy

Operational Point of Contact (OPC) with vendors, including Medical Writing Full Service Providers

Contractor/vendor selection, Medical Writing-specific content in contracts, and initiation and implementation of collaborations

Recommends policy/procedure-related modifications

Collaboration with Quality Assurance/Compliance for the management of responses to process audits

Collaborate with Global Development Training to develop, execute, and maintain Medical Writing Training and Curricula

Act as Process owner for Medical Writing SOPs and supportive documentation

Proactive resourcing of all MW activities, analyzing short- and long-term Medical Writing staffing needs, and distributing work appropriately among department members & external consultants/vendors

Management of outsourced writer assignments and activities

Proactive troubleshooting, problem resolution, and customer concern

Represents Medical Writing at cross-company and TA meetings

Articulate /resourcing strategy and timelines

Collaboration with Management to set the requirements for department guidelines, templates, timelines and SOPs to ensure compliance with applicable regulatory guidance and industry standards

Providing oversight to external writers/writing projects to ensure that results meet internal process and quality standards

Tracking development of Medical Writing documents

Performs as a strategic leader and technical expert, applying technical knowledge to solve highly complex matters

Provides leadership with input about departmental strategy, organizational goals, and current policies/procedures

This role might be for you if:

• Bachelor's degree (advanced degree preferred)
• Minimum of 10+ years of proven experience; preference to have 3+ years of Medical Writing experience.
• Minimum of 3+ years of management experience.
• Have strong organizational, interpersonal and communication skills, and be able to develop and present varied and unique ideas
• Have a good solid understanding of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Stamford , Director Medical Writing & Outsourcing, Other , Tarrytown, Connecticut