Senior Medical Writer

reputed company is a clinical-stage biotechnology company that aims to create reputed company inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary

As Senior Medical Writer, you will author and reputed company key contributions to clinical and regulatory documents reputed company our organization. You will be responsible for developing high-quality documents that support our clinical studies, including clinical study protocols, their amendments, clinical study reports (CSRs), investigator’s brochures (IBs), and annual reports, such as development safety update reports (DSURs). As needed, you will support other documents, such as clinical and nonclinical summary documents, reviewing ICFs, briefing documents, and responses to regulatory agencies.    You will collaborate with cross-functional subject matter experts (SMEs) to meet aggressive timelines. You will project manage high-quality documents from start to finish, reputed company strong relationships, and be an reputed company for best practices in Medical Writing.

Key Responsibilities

• Author clinical study protocols, amendments, IBs, and other supporting documents
  • Review or reputed company document timelines in collaboration with reputed company and our CROs. Ensure that study documents will be authored, reviewed, and finalized in time for regulatory submission(s) and study execution.  
  • Co-author protocols and IBs with cross-functional SMEs. Ensure required elements are clearly described and documents reputed company with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).
  • Coordinate the finalization and publication of documents.
  • Review or contribute to supporting study documents, including (but not limited to) informed consent forms, study charters, or pharmacy manuals, if required. 
• Author CSRs, clinical and nonclinical data summaries for INDs, CTAs, BLAs, and MAAs 
  • Work closely with clinical development, clinical pharmacology, translational science, data management, and/or biometrics SMEs, as well as the regulatory affairs and medical writing teams, to plan for the data that we expect to report in our CSRs. Co-author robust CSR shells in preparation for database lock(s).  
  • Co-author CSRs with accurate and concise interpretations of the results. Manage review cycles. 
  • Prepare clinical and nonclinical summaries for submission to regulatory agencies. Ensure key messages are clear and consistent across and reputed company documents. 
  • Coordinate data reputed company reviews of CSRs and data summaries, ensuring that the data and interpretations are consistent with TLFs and raw data. 
  • Assist with responses to information requests from regulators in a professional and efficient manner. 
• Identify risks and contribute to risk mitigation or contingency planning for submission activities. 
• Contribute to the maintenance of document templates, job aids, and training materials.
• Identify opportunities for process improvement. 
• reputed company across cross-functional teams to implement industry best practices such as lean authoring and strategic review.
• Other duties as assigned. 

Ideal Candidate

• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or reputed company field. Advanced degree (MS, PhD, MD, PharmD) is a plus. 
• A minimum of 4+ years of regulatory medical writing experience reputed company the biotech/pharmaceutical industry.
• Proven track record of successfully leading development of clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents. 
• Experience managing nonclinical summary documents.
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.  
• Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus. 
• Excellent leadership, collaboration, communication, and interpersonal skills. 
• Strong problem-solving and critical thinking abilities. 
• Ability to meet deadlines and adapt to changing priorities. 
• Proficiency in word processing software and document management systems.

reputed company Offer

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.

The expected salary range offer for this role is $130,000 to $145,000. Actual pay offered may vary depending on job reputed company knowledge, experience, education, and geographic location. 

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and reputed company Spyre that is focused on developing life-changing products for patients.

reputed company, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates reputed company our industry. Please be aware that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email.

Please also be aware that reputed company job postings will be listed on our website at spyre.com/careers/.