Senior Manager Medical
4 weeks ago
The Senior Manager, Medical & Regulatory Writing will be an integral part of MoonLake’s Clinical Development team. You will lead a team responsible for developing the content for submissions to regulatory agencies and other external stakeholders.
This role will partner closely with key internal and external stakeholders and requires critical thinking along with excellent scientific writing skills, the ability to interpret data and knowledge of regulatory life-cycle.
Key Accountabilities:
- Lead scientific contribution to the development of medical, regulatory and clinical documents to support MoonLake’s development programmes. This includes (not limited to) clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
- Lead and manage the medical and regulatory writing team along with use of external writing resources when necessary
- Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
- Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
- Work closely with subject matter experts to ensure their writing is of the highest standard of technical accuracy.
- Develop and support QC processes to ensure quality and accuracy within and between development documents.
- Lead the development of templates for core documents that ensure compliance and consistency
- Work with key functions to support the development of MoonLake’s in-house style guide to create a consistent and high-quality image across MoonLake's documents.
- Lead the development of processes, SOPs and other controlled documents, including for Medical and Regulatory writing activities
- Partners with Regulatory Affairs and cross-functional colleagues to understand the clinical development landscape e.g. regulatory requirements, competitor strategies and adapts to changes that may impact MoonLake development programs
Education:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
The Senior Manager, Medical & Regulatory Writing will be an integral part of MoonLake’s Clinical Development team. You will lead a team responsible for developing the content for submissions to regulatory agencies and other external stakeholders.
This role will partner closely with key internal and external stakeholders and requires critical thinking along with excellent scientific writing skills, the ability to interpret data and knowledge of regulatory life-cycle.
Key Accountabilities:
- Lead scientific contribution to the development of medical, regulatory and clinical documents to support MoonLake’s development programmes. This includes (not limited to) clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
- Lead and manage the medical and regulatory writing team along with use of external writing resources when necessary
- Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
- Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
- Work closely with subject matter experts to ensure their writing is of the highest standard of technical accuracy.
- Develop and support QC processes to ensure quality and accuracy within and between development documents.
- Lead the development of templates for core documents that ensure compliance and consistency
- Work with key functions to support the development of MoonLake’s in-house style guide to create a consistent and high-quality image across MoonLake's documents.
- Lead the development of processes, SOPs and other controlled documents, including for Medical and Regulatory writing activities
- Partners with Regulatory Affairs and cross-functional colleagues to understand the clinical development landscape e.g. regulatory requirements, competitor strategies and adapts to changes that may impact MoonLake development programs
Education:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
- Experience of writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations
- Experience in writing for clinical trials across a range of therapeutic areas and geographies, ideally with immunology/dermatology experience
- Previous experience in medical communications, editing and/or publishing would be advantageous
Skills/knowledge/behavioural competencies:
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
- Knowledge of ICH guidelines and data protection law applicable to medical writing.
- Excellent attention to detail
- Team player able to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
- Good time-management skills, resourcefulness, adaptability, flexibility and an ability to manage simultaneous priorities and adapt to changing timelines.
- An ability to work in a structured, independent manner within dynamic teams and a constructive, service‐oriented approach to challenging situations.
- Excellent command of the English language, both verbal and written communication skills
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). Demonstrate keen attention to detail and faultless grammar and spelling
- Ability to proactively identify risks and develop risk mitigation strategies
- Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
- Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity
- Works proactively using solid communication and influencing skills to effectively execute program goals
- Works effectively in a highly complex and fast-paced environment
- 2 days a week in our brand new Porto Office
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills. Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other. We unlock value: We aspire to create long-term value for investors and communities.
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