The Principal Medical Writer (PMW) is the accountable lead for his/her compound(s).
The PMW works closely with Medical Directors, Biostatisticians, Regulatory Liaisons, and others to develop high-quality clinical documents and is responsible for helping to drive document strategy, development, and resourcing.
PMWs will also write clinical documents (including Module 2 documents required for regulatory submissions) and oversee the work of junior/outsourced writers.
The PMW will also seek to improve MW processes and may work in larger process improvement teams within Global Development.
Job ResponsibilitiesWorks with the clinical team as accountable lead for assigned compounds with overall responsibility for clinical documents including CSRs, protocols, ICFs, narratives, IB and other regulatory documents in a variety of therapeutic areas
Leads MW effort on submission document writing, working closely with Medical Directors, Biostatisticians and/or Regulatory Liaisons
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
Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict
Oversees the work of junior and outsourced MWs and will also write documents independently
Reviews 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
Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
Remains compliant with internal training
Job Requirements
Education
Bachelor's degree (advanced degree preferred)
Experience
Minimum of 7 years relevant MW experience including strong understanding of biostatistics (relevant advanced degree may offset some of the experience requirement
Minimum 2 years management experience preferred
Expert knowledge of the clinical research process and regulations/guidelines
Expert clinical document reading, writing, and editing experience
Excellent organizational, interpersonal and communication skills
Excellent knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
Ability to manage multiple projects
Thorough understanding of 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 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.
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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