Senior Medical Writers in this area could focus on developing regulatory submissions, clinical trial protocols, and safety communications that shape how life-changing therapies reach patients. The opportunity centers on bringing deep scientific expertise and regulatory acumen to complex, high-stakes healthcare documentation. Please note the content of this advert does not represent a live vacancy. About the opportunity This is an opportunity to register your interest in future Senior Medical Writer roles within clinical development and regulatory affairs. Roles of this type could involve partnering across research, clinical operations, and regulatory teams to translate complex clinical data into clear, compliant documentation that supports patient safety and regulatory success. The work could take place within a collaborative, science-driven organization based in Chicago, Illinois, USA, where medical writers lead documentation strategy for therapeutic programs at critical development stages. You could have scope to mentor junior writers, shape submission strategies, and ensure data integrity across protocols, safety reports, and regulatory correspondence. Typical role overview

Location:

Chicago, Illinois, USA Type:

Permanent

•

Full-time Salary:

$130,000 - $190,000 per annum, dependent on experience

Domain:

Clinical development

• regulatory medical writing

• life sciences What you would do Typical responsibilities could include: Owning the development and delivery of clinical trial protocols, case report forms, and informed consent forms from conception through regulatory submission Leading the preparation of regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and safety updates Directing the creation of clinical study reports, safety summaries, and other regulatory documentation that ensure patient safety and data integrity Mentoring and developing junior medical writers, establishing best practices in medical writing and regulatory compliance Collaborating with clinical, research, quality, and regulatory teams to translate complex scientific data into clear, compliant documentation Managing multiple documentation projects simultaneously, maintaining timelines and quality standards under FDA and international regulatory frameworks Serving as a key stakeholder in regulatory strategy discussions and contributing to submission planning What you could bring Most roles of this type require the following: Must-have 10-15 years of medical writing experience, with at least 5+ years in a leadership or senior role Demonstrated expertise in regulatory medical writing, including clinical trial protocols, regulatory submissions (IND, NDA, BLA), and safety documentation Working knowledge of FDA regulations, ICH guidelines, GCP (Good Clinical Practice), and healthcare compliance standards Advanced degree in Life Sciences, Biology, Pharmacy, or a related field, or equivalent professional experience Strong scientific writing skills with the ability to translate complex clinical data for regulatory and clinical audiences Proven ability to lead teams, manage multiple projects, and maintain rigorous data integrity and quality standards Relevant professional certification (e.g., EMWA, AMWA) or equivalent demonstrated expertise Authorization to work in the United States Nice-to-have Experience with specific therapeutic areas (oncology, cardiovascular, immunology, or rare disease) Knowledge of international regulatory pathways (EMA, Health Canada, PMDA) Familiarity with electronic data capture (EDC) systems and clinical trial management platforms Project management certifications or experience in regulated environments What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Scope to influence regulatory strategy and contribute directly to bringing therapies to patients Leadership opportunity to mentor and develop medical writing talent Involvement in high-impact clinical programs at critical development stages Professional development support, including conference attendance and continuing education in regulatory affairs Competitive benefits package including health insurance (medical, dental, vision), paid time off, 401(k) matching, flexible work arrangements, and remote flexibility where supported by the role Potential for career progression toward Principal Medical Writer or Regulatory Affairs leadership roles Collaborative environment with cross-functional teams in clinical, research, and regulatory affairs About Specialist Staffing Group Specialist Staffing Group partners with organizations across life sciences, clinical development, and healthcare to build high-performing teams. We connect talented professionals with rewarding opportunities where scientific expertise, regulatory knowledge, and attention to detail make a measurable difference in patient outcomes. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.