Position - Temp - Sr. Medical Writer

Pay Range - $40/Hr - $50/Hr

Location - Armonk, NY / Tarrytown, NY

Duration - 12 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 their 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.    

As a Medical Writer, a typical data might include:

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 meetings

Drives document development meetings

Articulates document strategy and timelines

Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss 

Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly 

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

Leads processes and prioritizes; 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 ICFs)

Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience

May mentor junior staff

Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area.

To be considered for this role, you must meet the following requirements:

Education

Bachelor's degree (advanced degree preferred)

Experience

Minimum of 3 years of relevant MW experience including working knowledge of biostatistics.

Solid understanding 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

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