Director, Clinical Medical Writing

Zura Bio Limited (Nasdaq: ZURA)

United States

Sur place

USD 208 000 - 238 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Medical, Dental, and Vision Plans

Life and Disability Insurance

HSA/FSA

Equity Compensation

Bonus Program

401(k) with company match

Paid time off & holidays

Paid parental leave

Résumé du poste

Zura Bio Limited seeks an experienced Director of Clinical Medical Writing to lead planning, authoring, and delivery of high-quality clinical documents across its portfolio. You will oversee study-level documents, collaborate with cross-functional teams, and manage vendors to ensure timely, inspection-ready submissions.

You will drive writing standards, templates, and review processes while expanding the clinical writing function as the pipeline grows, with deep regulatory knowledge guiding

Qualifications

10+ years as a medical writer for regulated clinical documents.
Lead writer for protocols, CSRs, brochures, and submissions.
Experience across compounds to ensure messaging consistency.
Able to independently write and finalize documents.
Strong knowledge of AMA style and regulatory requirements.
Collaborates with Regulatory Affairs to ensure submission readiness.
Experience in biologics and integrating immunogenicity, safety, efficacy concepts.

Responsabilités

Lead writing and management of complex clinical documents across studies.
Prioritize timelines and deliverables with Project Management and Operations.
Act as Clinical Medical Writing lead on study teams and cross-functional projects.
Develop study-level document plans and ensure on-time, high-quality outputs.
Create integrated document plans with dependencies and review cycles.
Collaborate on statistical plans and data outputs for CSRs and narratives.
Ensure adherence to conventions, grammar, formatting, and templates.
Govern contract writers and vendors; ensure on-time performance.
Maintain knowledge of clinical development regulations and guidelines.

Connaissances

Clinical writing leadership

Regulatory submissions

Data interpretation

Cross-functional collaboration

FDA/EMA/ICH guidelines

Biologic product experience

Document standards

AI tools usage in writing

Vendor management

Formation

Bachelor's degree

Advanced degree in scientific field

Outils

SharePoint

Veeva

PleaseReview

Description du poste

Zura is a clinical‑stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‑mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach.

Zura is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity.

At Zura, we operate as One Zura. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining Zura means contributing to patient‑focused clinical development in a hands‑on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.

What You’ll Do

We are seeking a highly motivated and experienced Director of Clinical Medical Writing to join our dynamic team at Zura, a growing biotechnology company.

In this role, you will lead the planning, authoring, and delivery of high-quality clinical documents across Zura's portfolio. You will be responsible for clinical medical writing strategy and timely deliverables for one or more studies, projects, or programs, including oversight when contractors or vendors are used for initial writing. This role focuses on study‑level and clinical development documents, including protocols, protocol amendments, clinical study reports, investigator's brochures, informed consent‑related content, clinical narratives, clinical sections of submission‑supporting documents, and other documents that support clinical trial execution, data interpretation, public disclosure, health authority interactions, and regulatory submissions.

You will collaborate with cross‑functional subject matter experts in Clinical Development, Clinical Operations, Biostatistics, Data Management, Drug Safety, Regulatory Affairs, Clinical Pharmacology, Bioanalytical, Nonclinical, and CMC to meet aggressive timelines. You will manage high‑quality clinical documents from start to finish, develop strong relationships, and advocate for best practices in Clinical Medical Writing, including document standards, templates, review processes, and scalable ways of working. You will help grow the clinical medical writing function as Zura's pipeline expands.

Responsibilities

Collaborate with internal teams to lead, write, and manage complex clinical documents, including clinical protocols, protocol amendments, clinical study reports, investigator's brochures, clinical narratives, informed consent‑related content, and other study‑level documents.
Prioritize and track timelines and deliverables for multiple clinical studies and programs in collaboration with Project Management and Clinical Operations.
Serve as the Clinical Medical Writing lead on assigned study teams, clinical sub‑teams, and cross‑functional project teams.
Develop and own study‑level document plans, ensuring on‑time, high‑quality, inspection‑ready clinical writing deliverables.
Develop integrated clinical document plans across studies and programs, including expected dependencies, source documents, review cycles, decision points, and escalation pathways.
Collaborate with Biostatistics, Data Management, Clinical Development, and Safety on statistical analysis plans, tables, figures, listings, data outputs, and data interpretation to support efficient development of CSRs, investigator's brochures, narratives, and other data‑driven clinical documents.
Function as a subject matter expert within the department for assigned therapeutic or product areas.
Lead complex scientific key messaging and storyboarding meetings with cross‑functional teams, ensuring messages are clear and consistent within and across documents.
Independently assimilate and interpret complex clinical, safety, efficacy, biomarker, clinical pharmacology, and statistical source materials to shape accurate clinical messaging and support data‑driven decision‑making.
Ensure compliance with appropriate conventions, grammar, and formatting requirements, including formatting and hyperlinking.
Manage document review cycles; schedule and lead data interpretation meetings, comment resolution meetings, and other document‑related meetings.
Establish and oversee quality control processes, writing standards, templates, style guides, lexicons, and medical writing best practices to ensure documents are accurate, consistent, submission‑ready, and inspection‑ready.
Maintain strong knowledge of relevant clinical development regulations, requirements, and guidance associated with clinical trial documentation, including ICH E3, ICH E6, ICH E8, ICH E9, and applicable FDA, EMA, and regional guidance.
Partner with Clinical Development, Clinical Operations, Biostatistics, Data Management, Drug Safety, Regulatory Affairs, Clinical Pharmacology, Bioanalytical, and Nonclinical teams to ensure clinical document content and messaging align with study objectives, development strategy, data outputs, and operational timelines.
Lead the authoring of clinical sections and study‑level content for regulatory submissions and health authority interactions, including clinical contributions to briefing packages, responses to information requests, and other submission‑supporting documents.
Lead or support clinical key messaging, document storyboarding, data interpretation, and cross‑document consistency across protocols, clinical study reports, investigator's brochures, and related clinical documents.
Support clinical content for INDs, CTAs, briefing packages, annual reports, clinical CTD modules, BLA/NDA/MAA packages, and health authority responses, ensuring clinical messaging is scientifically accurate and aligned across documents.
Ensure clinical documents are developed with awareness of public disclosure, plain language, transparency, and downstream publication or registry‑related considerations, as applicable.
Select, oversee, and govern contract clinical medical writers, FSP partners, and vendors, ensuring high‑quality deliverables and on‑time performance.
Manage clinical medical writing resources, priorities, and risks across assigned studies or programs, escalating timeline, quality, or resourcing issues proactively.

Required Qualifications

10+ years of direct experience as a medical writer preparing regulated clinical documents in the pharmaceutical or biotechnology industry, including at least 5 years leading clinical medical writing deliverables for clinical studies or development programs.
Experience as the lead writer of key clinical documents, including protocols, protocol amendments, clinical study reports, investigator's brochures, clinical narratives, and clinical content supporting health authority interactions or regulatory submissions.
Experience working within or across compounds to ensure consistency of standards and messaging.
Ability to independently write and complete documents.
Extensive working knowledge of relevant FDA, EMA, PMDA, and ICH guidelines for clinical trial documentation, particularly ICH E3, ICH E6, ICH E8, and ICH E9, with working knowledge of CTD and eCTD expectations for clinical submission content.
Experience partnering with Regulatory Affairs and Regulatory Operations to ensure clinical documents are submission‑ready, appropriately formatted, and aligned with downstream regulatory requirements.
Experience contributing clinical content to INDs, CTAs, briefing books, annual reports, clinical CTD modules, BLA/NDA/MAA packages, and health authority response documents.
Experience writing clinical documents for biologic products, including monoclonal antibodies or other therapeutic proteins, with the ability to integrate immunogenicity, safety, efficacy, and clinical pharmacology concepts into clear clinical narratives.
Deep understanding of the drug development process, clinical trial design, biologic development, and how study‑level documents support overall development and BLA readiness.
Strong ability to assimilate and analytically interpret scientific data; experience preparing data tables and basic figures is required.
Experience reviewing and interpreting statistical analysis plans and TFL outputs to support clinical document development, data interpretation, and message consistency.
Proficient knowledge of American Medical Association (AMA) style guidelines.
Advanced ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
Excellent attention to detail and time‑management skills, with the ability to balance multiple projects simultaneously.
Ability to create and follow style guides, lexicons, and document templates.
Excellent written and oral communication skills, with the ability to clearly present technical information within and across functional areas.
Demonstrated high level of proficiency in Microsoft Word.
Experience with document management, review, and collaborative authoring systems such as SharePoint, Veeva, PleaseReview, or similar platforms.
Energetic, self‑motivated, hands‑on professional with a strong work ethic.
Ability to work collaboratively in a dynamic environment.
Strong desire and ability to be a team player, working with and leading others toward common goals.
Experience using AI software or managing vendors with this capability.

Preferred Qualifications

Previous experience mentoring junior writers, coaching contractors, or helping build a medical writing function in a growing biotechnology organization is a plus.
Experience working with Accenture Starting Point templates and add‑on toolbars is a plus.
Experience supporting regulatory inspections and Phase 3 readiness activities is preferred.

Education