Associate Director, Medical Writing

Celea Therapeutics; Deutschland; Hybrid; EUR 168.000 - 198.000; Vollzeit

Benefits dieser Stelle

Hybrid/Remote work option

Equity

Zusammenfassung

Celea Therapeutics is seeking an experienced Associate Director, Medical Writing to own regulatory documents for Phase 3 programs, including protocols, clinical study reports, and NDAs. You will guide writing standards, vendor management, and submission readiness while collaborating with Regulatory Affairs and Clinical teams.

Hybrid or remote work is available. The role reports to the Senior VP, Clinical Operations and Program Strategy and offers a competitive compensation package with equity,

Qualifikationen

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 8+ years of medical writing experience in biotech/pharma or CRO.
• Direct hands-on NDA/BLA/MAA submission experience required.
• Experience drafting CTD/eCTD documents to ICH guidelines.
• Ability to translate clinical data into clear narratives for regulators.
• Strong written and oral communication; capable of leading reviews.

Aufgaben

• Own medical writing for clinical programs and deliver regulatory-compliant documents on time.
• Author protocols, clinical study reports, ICH E3 documents, and safety narratives.
• Lead regulatory submission documents including FDA/EMA briefing materials.
• Drive end-to-end document lifecycle from timelines to QC and publishing in eCTD.
• Oversee vendor management, budgets, scope, and quality standards.
• Partner with Clinical Development, Biostatistics, Regulatory Affairs, and Pharmacovigilance to align data with strategy.
• Develop and improve writing processes, templates, and AI-enabled tools.
• Mentor and grow direct reports and contract writers.

Kenntnisse

Medical writing experience

NDA submission

CTD/eCTD

Regulatory writing

Cross-functional leadership

AI tools in writing

Clinical data interpretation

Vendor management

Project management

Ausbildung

Bachelor’s degree in life sciences

MS/PhD/PharmD preferred

Tools

Veeva Vault

PleaseReview

StartingPoint Templates

Jobbeschreibung

About Celea Therapeutics

Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for "sky," our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.

Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability - owning outcomes and acting like owners; transparency - talking straight and building trust; collaboration - achieving together what no one could alone; innovation - challenging accepted ideas and taking smart risks; and passion - bringing energy and heart to the mission.

Position Overview

As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Associate Director, Medical Writing to own the clinical and regulatory documents that carry our science to health authorities. Reporting to the Senior Vice President, Clinical Operations and Program Strategy, you will own medical writing strategy, standards, and delivery across the portfolio - while personally authoring the highest-stakes documents, from protocols and clinical study reports through the clinical modules of our planned NDA.

In the near term, your focus will be delivering Phase 3 protocols and amendments, clinical study reports, Investigator's Brochure updates, and health authority briefing documents on timelines that protect the program’s critical path. Over time, you will build the medical writing function - templates, style standards, vendor strategy, and submission-ready processes - and serve as a core contributor to NDA authoring and readiness, making you instrumental in guiding Celea through its next chapter.

This position is open to hybrid or remote work.

Key Responsibilities

• Own medical writing for Celea’s clinical programs; deliver scientifically rigorous, regulatory-compliant documents that are accurate, consistent, and on time.
• Author, edit, and finalize core clinical documents - protocols and amendments, informed consent form templates, clinical study reports, Investigator's Brochures, safety narratives, and clinical sections of the Development Safety Update Report.
• Lead authoring of clinical regulatory submission documents, including Module 2 summaries (2.5 Clinical Overview, 2.7 Clinical Summaries), integrated summaries of safety and efficacy, and briefing documents for FDA and international health authority meetings, in support of the planned NDA/MAA.
• Drive the document lifecycle end to end: build and hold authoring timelines, run comment resolution and review meetings, and shepherd documents through QC, approval, and submission-ready publishing in eCTD format.
• Oversee medical writing vendors and contract writers, including scope, budget, timelines, quality standards, and issue escalation.
• Partner cross-functionally with Clinical Development, Clinical Trial Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, and CMC to ensure documents accurately reflect the data and align with regulatory strategy and the target product profile.
• Ensure compliance with ICH E3 and E6(R3), FDA and EMA guidance, CONSORT, GPP, and internal SOPs; maintain document templates, style guides, and controlled terminology so quality is repeatable rather than heroic.
• Build and continuously improve medical writing processes, standards, and tools - including thoughtful use of AI and automation - so the function scales with the company.
• As we grow, recruit, mentor, and develop direct reports and contract writers.

Qualifications

Required

• Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree (MS, PhD, PharmD) is preferred; equivalent experience considered.
• 8+ years of medical writing experience in the biotech or pharmaceutical industry (or CRO), including substantial experience authoring documents for late-phase clinical programs.
• Direct, hands-on contribution to at least one NDA (or BLA/MAA) submission - authoring clinical modules such as the Clinical Overview, Clinical Summaries, or integrated summaries of safety and efficacy, through filing.
• Demonstrated expertise authoring protocols, clinical study reports, and Investigator's Brochures to ICH E3 and related guidance, with a working command of the CTD/eCTD structure.
• Ability to interpret clinical and statistical output - TLFs, SAPs, safety data - and translate it into a clear, defensible scientific narrative.
• Track record of delivering complex, high-visibility documents on tight timelines while managing multiple parallel workstreams and review cycles.
• Excellent written and oral communication skills, with the ability to lead cross-functional review discussions and drive consensus among senior stakeholders.
• Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
• Proficiency using AI tools to work smarter - curiosity about how technology can improve the quality and speed of your work.

Preferred

• Experience in respiratory, pulmonology, or fibrotic disease programs, or with small-molecule products in late-stage development.
• Experience building or standing up a medical writing function in a small or growing clinical-stage biotech, including template and process development.
• Experience with regulatory publishing systems and document management platforms (e.g., Veeva Vault, PleaseReview, StartingPoint Templates), and familiarity with AMA style.

Why Join Celea Therapeutics

• Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
• Shape the foundation of a Phase 3 biotech poised for significant growth.
• Collaborate with a passionate, mission-driven leadership team.
• Competitive compensation and equity package.

Compensation

Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $195,000-$230,000 plus bonus and equity. Where an offer lands within the range reflects the candidate’s experience, skills, and internal equity - and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.

Our Commitment

Celea Therapeutics is an equal opportunity employer. We evaluate every candidate against the requirements of the role using a structured, evidence-based process, and we make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.

For more information, visit www.celeatx.com or connect with us on Twitter @celeatx.

Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.

Base Pay Information

$1-$10 USD

Our Commitment

Celea Therapeutics is an equal opportunity employer. We evaluate every candidate against the requirements of the role using a structured, evidence-based process, and we make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.

For more information, visit www.celeatx.com or connect with us on Twitter @celeatx.