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Spyre Therapeutics is a prominent clinical-stage biotechnology company focused on developing next-generation treatments for inflammatory bowel disease (IBD) and other immune-mediated conditions. The company utilizes best-in-class antibody engineering, dose optimization, and rational therapeutic combinations to create innovative medicines aimed at improving patient outcomes. As part of their ongoing efforts, Spyre is seeking a Senior Medical Writer who will play a vital role in authoring key clinical and regulatory documents that support the company’s clinical studies and submissions.
The Senior Medical Writer position involves a combination of creativity and technical proficiency, requiring the selected candidate to create high-quality documents essential for clinical studies. Responsibilities include developing various documents such as clinical study protocols, amendments, clinical study reports (CSRs), investigator’s brochures (IBs), and annual reports like development safety update reports (DSURs). This individual will collaborate with cross-functional subject matter experts (SMEs) to ensure that all documentation meets regulatory requirements and timelines.
The successful candidate will have a variety of responsibilities, including but not limited to the following:
Authoring and collaborating on clinical study protocols, amendments, and IBs throughout their development.
Coordinating document timelines in partnership with internal teams and contract research organizations (CROs), ensuring that all materials are prepared in time for regulatory submissions and study execution.
Co-authoring and managing the review cycles of study documents, ensuring compliance with ethical and regulatory standards by working closely with stakeholders to address any feedback.
Finalizing and overseeing the publication of key documents while ensuring that they meet the required quality standards.
Creating CSRs and clinical and nonclinical data summaries to support Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), and Marketing Authorizations (MAAs).
Collaborating with clinical development, pharmacology, and biometrics teams to prepare reports that reflect data integrity and accurate interpretation of study results.
Maintaining document templates and providing training materials to enhance the efficiency of the writing process.
Identifying process improvement opportunities and advocating best practices in medical writing within cross-functional teams.
The ideal candidate for the Senior Medical Writer position will meet the following qualifications:
A Bachelor's degree in a scientific discipline like Pharmacy, Chemistry, or Biology, with an advanced degree (such as MS, PhD, MD, or PharmD) regarded as a plus.
At least 4+ years of regulatory medical writing experience within the biotech or pharmaceutical industry, demonstrating a proven capability in leading the development of essential clinical and regulatory documents.
Strong knowledge of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines.
Excellent leadership and collaboration skills, coupled with effective communication and interpersonal abilities.
A robust problem-solving and critical thinking mindset, with a proven ability to meet tight deadlines and manage changing priorities.
Proficiency in word processing and document management software is highly beneficial.
Spyre Therapeutics offers a competitive salary range for the Senior Medical Writer position, estimated between $130,000 to $145,000 annually. The final salary may vary based on applicants' job-related knowledge, experience, educational background, and geographical location. The company is dedicated to providing an attractive benefits package that includes:
Unlimited paid time off (PTO), increasing work-life balance.
Two company-wide shutdowns for all employees each year.
Opportunities for professional development, allowing employees to sharpen their skills in a fast-paced environment that encourages continuous learning.
A remote working environment, with periodic in-person meetings aimed at fostering collaboration in solving complex problems and building relationships among teams.
Spyre Therapeutics prides itself on being an equal opportunity employer committed to creating a diverse workforce. The recruitment process emphasizes inclusivity, without discrimination based on various personal characteristics. The company seeks to build a solid team that reflects a range of experiences and perspectives, contributing to developing life-changing products for patients.
In an effort to protect candidates, Spyre Therapeutics has also taken measures to inform prospective employees about potential email scams targeting job seekers in the biotech industry, ensuring that communication occurs through official company channels only.
For job seekers interested in the biotechnology field, the Senior Medical Writer position at Spyre Therapeutics presents a remarkable opportunity. Individuals who meet the specified requirements and are passionate about contributing to the development of impactful medical solutions are encouraged to apply and become part of a forward-thinking company dedicated to improving healthcare outcomes.
This job offer was originally published on remotive.com
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