Senior Regional Vice President of Sales, Clinical Documentation
CorroHealth
SFDC
Senior Medical Writer
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $130,000 - $145,000 per year
Job Level
Senior
About the role
- Author clinical study protocols, amendments, IBs, and other supporting documents
- Review or develop document timelines in collaboration with our team 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 comply 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 within documents.
- Coordinate data integrity 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.
- Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.
- Other duties as assigned.
Requirements
- Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus.
- A minimum of 4+ years of regulatory medical writing experience within 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.
Benefits
- 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 base 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 complex problems and build relationships.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study protocolsinvestigator's brochuresclinical study reportsregulatory submission documentsnonclinical summary documentsdata integrity reviewsrisk mitigationprocess improvementlean authoringstrategic review
Soft skills
leadershipcollaborationcommunicationinterpersonal skillsproblem-solvingcritical thinkingadaptabilitytime management
Certifications
Bachelor's degreeMSPhDMDPharmD
