Senior Director, Medical Writing
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Director, Medical Writing at Parabilis Medicines shaping documentation strategy for clinical programs. Overseeing authorship and quality of critical medical and regulatory documents.
Responsibilities:
- Lead medical writing strategy and execution across clinical development programs, ensuring timely delivery of high-quality documents aligned to corporate and regulatory objectives.
- Collaborating with the Clinical Leader, serve as the chief author or lead reviewer for key documents including:
- Clinical Protocols and Amendments
- Investigator Brochures
- Clinical Study Reports (CSRs)
- Informed Consent Forms
- Regulatory submission components (e.g., IND/IMPD documents, briefing books, safety updates, module content)
- Clinical-scientific narratives and safety summaries
- Partner with Regulatory and Clinical leaders to develop documentation plans and timelines for major milestones (Phase transitions, Health Authority meetings, submissions).
- Oversee and manage external writing vendors, freelancers, and CRO deliverables; ensure consistent standards, templates, style guides, and quality control processes.
- Develop and maintain medical writing templates, SOPs, and best practices to support high-quality, efficient document generation across the organization.
- Ensure all documents meet ICH, GCP, and global regulatory requirements.
- Contribute to story development, message alignment, and scientific accuracy across Parabilis’ clinical and regulatory communications.
- Mentor cross-functional authors and reviewers on writing best practices and effective documentation strategies.
- Play a leadership role within Clinical Operations, helping drive operational excellence, cross-functional alignment, and a patient-focused mindset.
Requirements:
- Advanced degree in a scientific discipline (MS, PharmD, PhD, MD) or equivalent experience.
- 15+ years of relevant medical writing experience in the biotechnology or pharmaceutical industry, including leading writing strategy for clinical-stage programs.
- Proven expertise with clinical and regulatory documents (protocols, CSRs, IBs, regulatory submissions).
- Proven track record of delivery and utilization of new techniques & approaches such as AI/ML to ensure efficiency and accurate production of documents.
- Strong understanding of GCP, ICH guidelines, and global regulatory expectations.
- Experience working in cross-functional, fast-paced development environments.
- Demonstrated ability to manage vendors and complex documentation workflows.
- Experience supporting early-phase oncology programs.
- Experience preparing documentation for Health Authority interactions (FDA, EMA).
- Familiarity with novel modalities, platform technologies, or mechanisms requiring clear scientific translation.
- Ability to influence without authority and build trusted relationships across functions.
Benefits:
- an annual target bonus
- equity
- a comprehensive suite of competitive benefits designed to support our employees’ overall well-being
Similar Jobs
Content Writer
Content Manager shaping narrations at Claravine, translating technical concepts for audiences. Collaborating across channels and teams to craft engaging narratives in content marketing.
Akademischer Ghostwriter – Mathe, Naturwissenschaften, Technische Fachbereiche
Ghostwriter providing academic writing services in mathematics and technical fields. Direct interaction with clients through Meet your Writer platform without agency involvement.
Academic Ghostwriter, Law
Freelance Ghostwriter specializing in law and legal sciences. Offering services directly to clients through Meet your Writer platform without agency involvement.
AI Script Writing Intern – Political Focus
AI Script Writing Intern creating political personas for a media outlet focused on reducing partisanship. Involves persona development, voice establishment, and script writing.
Proposal Writer
Proposal Writer developing proposals and responses for EVERSANA, collaborating across functional teams and managing timelines for deliverables.
Bid Writer – Social Value Expertise
Bid Writer seeking content plan and write responses for public sector tenders. Collaborating with teams, expertise in social value and ESG priorities required.
Director, Medical Writing
Director of Medical Writing at Madrigal Pharmaceuticals focusing on leading medical writing initiatives for clinical trials and regulatory documents related to MASH therapies.
Content Writer, Mandarin Speaker
Senior Content Writer creating engaging content for web and print aimed at iGaming audiences. Collaborating with teams to ensure quality and consistency while covering live events.
Construction Podcast Script Writer
Podcast Script Writer crafting compelling narrative episodes for construction industry's original series. Collaborating with a team to develop scripts that translate complex ideas and personal stories.
B2B ERP Writer
B2B ERP Writer crafting engaging content for a specialized ERP consulting firm focused on mid-market manufacturers. Building content that resonates with readers in the technical niche of ERP solutions.
AI in Construction Writer
Content Writer developing thought leadership on AI in construction, translating complex topics into engaging narratives. Collaborating with teams to produce articles, reports, and interactive content.
LinkedIn Content Specialist, Ghostwriter
LinkedIn Content Specialist managing and growing professional presence on LinkedIn with strategic ghostwriting and visual content. Engaging audience and analyzing effectiveness for optimal brand impact.
Product Writer – Sales Force
Product Writer focusing on Content Design, defining writing norms and creating reusable text components. Collaborating with designers and developers in a remote work environment.
Senior Writer – MedTech Surgery
Senior Writer for MedTech Surgery developing clinical evaluation and safety reports for innovative surgical technologies. Collaborating with cross-functional teams in the medical device sector at Johnson & Johnson.
Senior Writer – MedTech Surgery
Senior Writer managing Clinical Evaluation Reports and Safety Reports for MedTech Surgery team at Johnson & Johnson. Overseeing scientific writing and collaborating with cross-functional teams.
English, Academic Writer
English & Academic Writer for GPTZero writing SEO-optimized blog posts on education and writing. Collaborating with communities to gather insights and optimize content for audiences.
Manager Contract Development – Payer Contract Writer
Manager, Contract Development – Payer Contract Writer at Amgen, integral to commercial contracting success, drafting and processing customer contracts to assist in serving patients.
Report Writer, Applications Developer
Clinical Business Analyst responsible for designing and maintaining reports within Epic EHR system. Regularly collaborates with end users to define specifications and timelines for report delivery.
Junior Content Writer
Junior Content Writer supporting FxPro’s global campaigns by producing persuasive marketing content. Collaborating with teams to ensure consistency and effectiveness in messaging across various channels.
Associate Director, Medical Writing
Associate Director of Medical Writing at argenx developing complex regulatory documents for autoimmune drug development. Collaborating with cross-functional teams to ensure compliance with medical writing standards.