Senior Manager, Medical Writing

Moderna Therapeutics; Melbourne; Hybrid; AUD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive healthcare

Well‑being programs

Family building benefits

Paid time off

Discretionary year‑end shutdown

Job summary

Moderna Therapeutics in Melbourne seeks a senior medical writer to lead planning, development and delivery of clinical and regulatory documents.

You will drive strategic document plans, manage multiple deliverables, and collaborate with cross‑functional teams to ensure scientific accuracy and regulatory compliance across global programs.

Qualifications

• Advanced degree (preferred) with approximately 4 years of relevant experience, or bachelor’s degree with approximately 9 years of relevant experience.
• Excellent interpersonal skills with internal and external stakeholders.
• Leadership skills to guide projects and collaborate with less experienced colleagues.
• Business acumen to align medical writing with development strategy.
• Strong communication, attention to detail and ability to manage multiple tasks.

Responsibilities

• Lead clinical and regulatory medical writing activities across planning, development and delivery of documents.
• Develop and manage strategic document plans for submissions with timelines and milestones.
• Oversee multiple writing deliverables, manage risks, and ensure deadlines.
• Strengthen cross‑functional collaboration to ensure scientific consistency across documents.
• Support global delivery with follow‑the‑sun coordination and regional needs.

Skills

Medical writing

Regulatory documentation

Project management

Cross‑functional collaboration

Strategic thinking

Independent judgment

Leadership without people management

Generative AI awareness

Education

Advanced degree (preferred)

Bachelor’s degree + 9 years’ experience

Tools

Microsoft Office

Medical writing software

Job description

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Melbourne, a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact. At Moderna, you will play a pivotal role in transforming complex clinical data into clear, scientifically rigorous and regulatory‑compliant documentation that advances our clinical development programs. Reporting to the Senior Director of Medical Writing Delivery and Excellence, you will drive the planning, coordination, authoring and delivery of high‑quality clinical and regulatory documents while collaborating with cross‑functional teams across time zones. Through your technical expertise, strategic judgment and commitment to operational excellence, you will help strengthen our medical writing capabilities and contribute directly to the advancement of innovative mRNA medicines for patients.

Here’s What You’ll Do:

• Lead clinical and regulatory medical writing activities: Apply advanced conceptual and practical knowledge of medical writing principles, scientific communication and regulatory documentation to plan, develop, author, review and deliver accurate, scientifically robust clinical and regulatory documents supporting Moderna's clinical development programs, from initial planning through final draft delivery.
• Drive strategic document planning and execution: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions, establishing clear deliverables, timelines, dependencies and review milestones. Coordinate medical writing activities to ensure timely, efficient execution while maintaining scientific integrity and alignment with broader clinical development objectives.
• Deliver operational excellence through project management: Independently oversee multiple medical writing deliverables, proactively identifying risks, resolving competing priorities and ensuring deadlines are achieved. Adapt functional plans and priorities to meet short‑term operational objectives while maintaining visibility of program‑level requirements and longer‑term development goals.
• Strengthen cross‑functional scientific collaboration: Partner closely with clinical development, regulatory and other relevant cross‑functional stakeholders to ensure scientific consistency, accuracy and integration across clinical and regulatory documents. Communicate complex scientific information effectively, explain difficult or sensitive issues and build consensus when stakeholders hold different perspectives.
• Enable seamless global delivery and regional coordination: Collaborate closely with the Medical Writing Delivery and Excellence team to support effective “follow‑the‑sun” working practices, including coordinated time‑zone hand‑offs, continuity of document development and efficient cross‑regional collaboration. Address regionally specific activities, requirements and processes as needed to maintain high‑quality, timely deliverables.
• Ensure regulatory compliance and scientific quality: Maintain rigorous adherence to applicable regulatory requirements, industry standards, corporate guidelines and established medical writing practices. Implement and oversee quality control processes throughout document development and review, ensuring accuracy, completeness, consistency, traceability and scientific credibility.
• Translate complex clinical data into compelling scientific narratives: Critically interpret, synthesize and present clinical data and other complex scientific information, transforming technical findings into coherent, evidence‑based clinical and regulatory documentation that supports informed decision‑making and regulatory review.
• Maintain document accuracy throughout development: Proactively update, revise and refine clinical and regulatory documents to incorporate emerging clinical information, evolving program requirements, stakeholder feedback and relevant regulatory changes, ensuring documentation remains current and fit for purpose.
• Exercise independent judgment and solve complex challenges: Navigate complex medical writing and regulatory documentation challenges by evaluating multiple sources of information, questioning existing approaches and identifying practical solutions. Apply sound scientific judgment and introduce new perspectives where established processes may benefit from improvement.
• Contribute to medical writing strategy and continuous improvement: Provide expert input into departmental goals, objectives and initiatives aligned with Moderna's broader business and clinical development strategy. Apply knowledge of medical writing best practices, organizational interfaces, industry developments, competitive dynamics and market differentiators to strengthen functional capabilities and operational effectiveness.
• Provide functional leadership through expertise and influence: Operate as a senior individual contributor, leading functional projects and programs without direct people‑management responsibility. Guide internal stakeholders, external vendors and cross‑functional partners, share technical knowledge, mentor less‑experienced colleagues and promote effective collaboration and consistent medical writing standards.
• Explore digital innovation and Generative AI opportunities: Contribute to the evaluation and responsible adoption of digital tools, automation and Generative AI‑enabled approaches that could improve medical writing workflows, document planning, scientific information synthesis and quality review, while maintaining appropriate human oversight, scientific accuracy, confidentiality and regulatory compliance.

The key Moderna Mindsets you’ll need to succeed in the role:

“We act with dynamic range, driving strategy and execution at the same time at every step.”

“We pivot fearlessly in the face of new data.”

Here’s What You’ll Bring to the Table:

Education and Years of Experience:

Advanced degree (preferred) with approximately 4years of relevant experience OR bachelor’s degree with approximately 9years of relevant experience.

Interpersonal Skills:

Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross‑functional team members to adopt a different point of view. Ability to explain difficult or sensitive information; work to build consensus.

Leadership Skills:

Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short‑term service and/or operational objectives. Ability to lead functional projects or programs; mentor and collaborate with colleagues with less experience.

Business Expertise:

Knowledge of best practices and how medical writing integrates with others within organization sub‑function; is aware of the competition and the factors that differentiate them in the market.

Communication Skills:

Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.

Quality:

Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

Technical Skills:

Proficiency in Microsoft Office and familiarity with medical writing software.

Our Working Model

As we build our company, we have always believed an in‑person culture is critical to our success. Moderna champions the significant benefits of in‑office collaboration by embracing a 70/30 work model. This 70% in‑office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well‑being with access to fitness, mindfulness, and mental health support.
• Family building benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
• Savings and investments to help you plan for the future.
• Location‑specific perks and extras.
• The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world‑class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. Moderna is a place where everyone can grow. Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at [e-mail].

Reasonable Accommodation Notice

Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.