Senior Medical Writer

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: ​

• 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
• 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 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
• Remains compliant with internal training

This role might be for you if can: ​

• 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

To be considered for this opportunity, you must have the following:

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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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