Senior Medical Writer

Warren, OH - USA

Monthly Salary: $ 128600 - 210000

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

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:

Bachelors 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 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 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 Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons 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 Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$128600.00 - $210000.00

Required Experience:

Senior IC

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:

Bachelors 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