Senior Medical Writer

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Overview of Spyre Therapeutics

Spyre Therapeutics is a biotechnology company focused on developing next-generation treatments for inflammatory bowel disease (IBD) and other immune-mediated diseases. Utilizing advanced antibody engineering, strategic drug combinations, and precision medicine, Spyre aims to transform patient outcomes in the biotech field. Their product pipeline showcases their commitment to innovation and patient care, which includes extended half-life antibodies targeting key mediators such as α4β7, TL1A, and IL-23.

Role Summary

The position of Senior Medical Writer plays a pivotal role in the organization, responsible for authoring and contributing to a variety of clinical and regulatory documents essential for clinical studies. This includes a range of documentation like clinical study protocols, amendments, clinical study reports (CSRs), investigator’s brochures (IBs), annual reports, and development safety update reports (DSURs). The successful candidate will also support the review of other valuable documents including informed consent forms (ICFs) and briefing documents.

In this role, the Senior Medical Writer will collaborate closely with cross-functional subject matter experts (SMEs) to adhere to strict deadlines while managing projects from inception to completion. The ideal candidate is expected to cultivate strong relationships across teams and advocate for best practices in medical writing.

Key Responsibilities

The Senior Medical Writer's responsibilities include:

• Authoring critical clinical study documents: You will be tasked with preparing and managing the timelines for clinical document development, ensuring timely submissions for regulatory approvals.

• Co-authoring with stakeholders: Collaboration with various SMEs is crucial for ensuring accurate and compliant protocols.

• Document finalization and publication management: You will take on the responsibility of coordinating the finalization and dissemination of documents after thorough review cycles with necessary stakeholders.

• Clinical Study Reports (CSRs): You will author CSRs and summaries for regulatory submissions (INDs, CTAs, BLAs, and MAAs), working closely with teams to ensure accuracy and clarity.

• Risk identification and mitigation: Understanding and identifying potential risks in submission activities, and contributing to contingency planning will be part of your duties.

• Process excellence: You will also work on maintaining and improving document templates and job aids, making sure best industry practices are followed.

Required Skills and Qualifications

To excel in the Senior Medical Writer position, candidates should showcase:

• A Bachelor's degree in a scientific discipline; advanced degrees (MS, PhD, MD, PharmD) are highly regarded.
• A minimum of 4+ years of experience specifically in regulatory medical writing within the biotech or pharmaceutical industry.
• Proven expertise in managing clinical documents such as protocols, amendments, IBs, CSRs, and more.
• Strong knowledge of global pharmaceutical regulations including FDA, EMA, and ICH requirements.
• Excellent leadership and interpersonal skills paired with the ability to adapt to changing priorities.
• Proficiency in relevant software tools, notably word processing software and document management systems.

Work Environment and Culture

Spyre Therapeutics offers a work environment that is both fast-paced and dynamic. Employees are encouraged to engage proactively, shape the company culture, and contribute to the mission of developing life-changing medicines. The company not only values contributions but also promotes a culture of learning and professional development, preparing you for growth in your career.

Compensation and Benefits

Spyre Therapeutics provides an attractive compensation package that is competitive within the industry:

• Expected salary range: $140,000 to $157,000, with variations depending on experience, education, and geographic location.
• Performance bonuses and equity grant opportunities
• Unlimited Paid Time Off (PTO), fostering a good work-life balance.
• Two company-wide shutdowns annually to rejuvenate employees.
• Commitment to employee professional growth through various development opportunities.
• A hybrid work environment with both remote flexibility and occasional in-person meetings for collaboration.

Commitment to Diversity

Spyre Therapeutics is an equal opportunity employer dedicated to building a diverse team. They prioritize a workplace where all are respected, regardless of race, religion, gender, age, sexual orientation, or other characteristics. The company aims to recruit talent from varied backgrounds to strengthen and diversify their workforce.

Attention to Job Seekers

Candidates are cautioned against employment scams, particularly within the biotech industry. Spyre Therapeutics strictly uses the domain “@spyre.com” for email communications and never asks for any purchases or personal information during the recruitment process. All genuine job opportunities will be posted on their official website.

This job offer was originally published on remotive.com