SENIOR DIRECTOR, MEDICAL WRITING

Job Description

SENIOR DIRECTOR, MEDICAL WRITING

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ABOUT THE COMPANY

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Helus Pharma (NASDAQ: HELP) is a clinical stage biopharmaceutical company empowering the healing process by turning Novel Serotonergic Agonists ("NSAs") into Breakthroughs in Mental Health.

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Founded in 2019, the company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. Helus Pharma is set to transform the mental health treatment landscape with key near-term milestones including its lead program HLP003, which has been granted FDA Breakthrough Therapy Designation, in Phase 3 development for the adjunctive treatment of Major Depressive Disorder, and HLP004 in development for generalized anxiety disorder.

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Helus Pharma has a robust pipeline of proprietary NSAs with potential for expansion into additional mental health indications with high unmet need. The company's mission to help minds heal is supported by a strong intellectual property portfolio and a work force that is driven by compassion and the urgent need for better mental health solutions. The Helus Pharma team is working together to build a pathway to make accessible, scalable, and transformative care available to millions of people worldwide.

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POSITION PURPOSE:

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The Senior Director, Medical Writing is responsible for leading the strategic development, oversight, and execution of scientific and medical writing activities across Helus Pharma’s clinical development portfolio. This role provides leadership for the preparation of high-quality regulatory, clinical, and scientific documents supporting Phase 1–3 programs, regulatory submissions, publications, and broader Medical Affairs initiatives within a highly regulated global environment.

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Reporting into the Medical Affairs organization, the Senior Director serves as a cross-functional scientific leader partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations, and external vendors to ensure the delivery of scientifically rigorous, compliant, and submission-ready documentation. The role also plays a key part in establishing scalable medical writing processes, standards, and operational infrastructure to support Helus Pharma’s advancing pipeline of Novel Serotonergic Agonists (NSAs).

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This individual will contribute strategic insight to evidence generation and scientific communication activities while ensuring alignment with FDA, EMA, ICH, and other applicable global regulatory standards.

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CORE ACCOUNTABILITIES:

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• Lead the strategic planning, authoring oversight, and delivery of clinical and regulatory writing activities across Helus Pharma development programs.
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• Oversee the preparation and review of key regulatory documents including clinical study protocols, investigator brochures, clinical study reports (CSRs), briefing documents, IND/NDA submission components, safety narratives, and annual reports.
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• Direct the development of scientific communication materials including manuscripts, abstracts, congress presentations, medical response documents, FAQs, and educational content.
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• Establish and maintain medical writing standards, templates, style guides, and document quality processes aligned with global regulatory expectations.
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• Ensure all medical and scientific documents are scientifically accurate, clearly articulated, and compliant with FDA, EMA, ICH, GCP, and internal standards.
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• Serve as a strategic partner to Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure consistency and alignment of scientific messaging.
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• Manage document timelines, resource allocation, and vendor oversight to support clinical milestones and regulatory submission objectives.
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• Lead cross-functional document review processes and facilitate resolution of scientific and editorial comments across stakeholders.
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• Provide scientific interpretation and synthesis of clinical data to support regulatory, publication, and medical communication strategies.
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• Drive continuous improvement initiatives related to medical writing workflows, document management systems, and operational efficiencies.
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• Support inspection readiness and audit activities through maintenance of compliant documentation practices and version control processes.
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• Mentor and provide leadership to internal medical writers and external contract writing teams, fostering high standards of scientific communication and execution.
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• Contribute to publication planning and evidence dissemination strategies supporting Helus Pharma’s CNS and mental health portfolio.
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• Monitor evolving regulatory guidance and industry best practices related to medical writing and scientific communications.
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• Represent Medical Writing within governance committees, development team meetings, and strategic planning initiatives.
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EDUCATION AND EXPERIENCE:

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• PharmD, PhD, MD, or other advanced scientific degree in life sciences, pharmacy, medicine, or a related discipline required.
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• Minimum 12+ years of medical writing experience within the biotechnology or pharmaceutical industry, including significant experience supporting clinical-stage development programs.
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• Demonstrated leadership experience within Medical Writing, Medical Affairs, or Regulatory Writing functions in a global regulated environment.
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• Strong knowledge of FDA, EMA, ICH, GCP, and global regulatory submission requirements.
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• Proven experience authoring and overseeing complex regulatory and clinical documents supporting Phase 2 and Phase 3 programs.
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• Experience supporting NDA, IND, or equivalent global regulatory submissions strongly preferred.
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• Solid understanding of CNS, psychiatry, neurology, or mental health therapeutic areas preferred.
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• Strong scientific interpretation skills with the ability to synthesize complex clinical and statistical data into clear scientific narratives.
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• Experience collaborating across Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Commercial organizations.
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• Expertise with document management systems, publication planning processes, and electronic submission environments.
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• Strong project management and organizational skills with the ability to manage multiple concurrent priorities and aggressive timelines.
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• Exceptional written, editorial, and verbal communication skills with strong attention to detail and scientific accuracy.
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• Experience managing external medical writing vendors and contract resources preferred.
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• Ability to operate effectively within a fast-evolving clinical-stage biotechnology environment.
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