Senior Medical Writer
Centessa Pharmaceuticals
August 13, 2026
On-site
United States
Clinical Research and Development
Key Responsibilities:
- Author and support medical writing content, including study-level documents (clinical protocols/amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA documents, and NDA/MAA clinical modules and summaries.
- Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management.
- Partner with internal/external writers to complete deliverables.
- Oversee document preparation end-to-end: kick-off/planning, drafting, manage review cycles, incorporate feedback/revisions, address QC/QA findings, and deliver final versions on timeline.
- Ensure clarity, consistency, and proper formatting of clinical documents.
- Maintain compliance with GCP, ICH, eCTD, and company guidelines.
- Interpret complex clinical data.
- Demonstrate strategic thinking and review capabilities.
- Contribute to SOPs, templates, and document standards.
Qualifications:
- PhD, PharmD, or Master’s in a scientific/clinical discipline or English.
- 4+ years medical writing or relevant pharma industry experience; at least 2 years sponsor-level clinical/regulatory medical writing.
- Previous neuroscience experience strongly preferred.
- Strong organizational, communication, and influencing skills; prioritize/multitask and meet tight timelines.
- Flexibility with evolving priorities.
- Knowledge of drug development, biostatistics, and medical terminology; basic scientific methodology.
- Regulatory submission knowledge (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction.
- Proficiency in Microsoft Word (advanced features) and document management/collaborative platforms (e.g., Veeva Vault, Please Review).
- Ability to work independently and collaboratively in a fast-paced cross-functional environment.
- Highly accurate, detail-oriented, professional; excellent interpersonal skills.
Benefits/Compensation:
- Base salary range: $140,000.00–$175,000.00; eligible for a discretionary annual bonus; 401(k) and comprehensive medical/dental/vision/life insurance, generous paid time off, and health/wellness program.
Work Location:
- US-based, occasional travel.
Position: Full-Time, Exempt.
- Author and support medical writing content, including study-level documents (clinical protocols/amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA documents, and NDA/MAA clinical modules and summaries.
- Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management.
- Partner with internal/external writers to complete deliverables.
- Oversee document preparation end-to-end: kick-off/planning, drafting, manage review cycles, incorporate feedback/revisions, address QC/QA findings, and deliver final versions on timeline.
- Ensure clarity, consistency, and proper formatting of clinical documents.
- Maintain compliance with GCP, ICH, eCTD, and company guidelines.
- Interpret complex clinical data.
- Demonstrate strategic thinking and review capabilities.
- Contribute to SOPs, templates, and document standards.
Qualifications:
- PhD, PharmD, or Master’s in a scientific/clinical discipline or English.
- 4+ years medical writing or relevant pharma industry experience; at least 2 years sponsor-level clinical/regulatory medical writing.
- Previous neuroscience experience strongly preferred.
- Strong organizational, communication, and influencing skills; prioritize/multitask and meet tight timelines.
- Flexibility with evolving priorities.
- Knowledge of drug development, biostatistics, and medical terminology; basic scientific methodology.
- Regulatory submission knowledge (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction.
- Proficiency in Microsoft Word (advanced features) and document management/collaborative platforms (e.g., Veeva Vault, Please Review).
- Ability to work independently and collaboratively in a fast-paced cross-functional environment.
- Highly accurate, detail-oriented, professional; excellent interpersonal skills.
Benefits/Compensation:
- Base salary range: $140,000.00–$175,000.00; eligible for a discretionary annual bonus; 401(k) and comprehensive medical/dental/vision/life insurance, generous paid time off, and health/wellness program.
Work Location:
- US-based, occasional travel.
Position: Full-Time, Exempt.