The Medical Writer (MW) works with team members to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to resolve issues and escalate problems, as necessary.
As a Medical Writer, a typical day may include:
Works with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to manage and facilitate completion of documents
Ensures adherence to internal standards and procedures
Maintains document standardization via model documents/templates and appropriate peer review
Remains current with writing guidelines and industry standards, participates in educational opportunities, reads professional publications
You might be right for this role, if you:
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
Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
Remains aligned with internal training
To be considered for this role, you must have:
Bachelor's degree (advanced degree preferred)
1yr of relevant experience
Awareness of the clinical research process and regulations/guidelines
Scientific and technical reading, writing, and editing skills
Organizational, interpersonal and communication skills
Working knowledge of MS WORD, Adobe Acrobat, PowerPoint, and familiarity with electronic document management systems
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.
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.
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