Position - Temp - Senior Medical Writer
Pay Range - $43.75/hr - $56.84/hr
Location - Armonk, NY / Basking Ridge, NJ
Duration - 9 Months

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.    

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

Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided

Represents MW at meeting and drives document development meetings

Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development

Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict

May review the work of junior and outsourced MWs

May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion

Writes in plain language style as appropriate (eg, for ICF), explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience

This job might be for you if you have:

Strong knowledge of the clinical research process and regulations/guidelines

Clinical document reading, writing, and editing experience

Strong organizational, interpersonal and communication skills

Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems

Ability to manage multiple projects

Familiarity with ICH GCP guidelines

To be considered for this role, you must have

Bachelor's degree (advanced degree preferred) and minimum of 3 years of relevant MW experience including working knowledge of biostatistics.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third-party solicitation