Full time. Remote. Ideal Locations: UK, Spain, Portugal, Greece, Poland, Italy, South Africa.

We are on a mission to deliver solutions that bring life-changing treatments to patients faster.

But we can´t do it alone.  

We are seeking an reputed company Senior Regulatory Medical Writer and a Medical Writer II to reputed company authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner.

This is why we need you. Join reputed company. Your job matters.

WHAT YOU WILL DO

Embedded in the team of one of the world´s leading pharma companies, you will be one of the primary Regulatory Medical Writers, project leading the Development Cycle for high-complexity Phase II-IV clinical regulatory documents.

We´ll trust you to spearhead the entire process, from initial planning and coordination through reputed company stages of development, culminating in the final delivery to the sponsor.

From the variety of documents you will work on (Investigator´s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory responses, etc.,) your contribution will be essential developing:

• Protocols and

• Clinical Study Reports (CSRs)

With minimal supervision, during Planning stage, you will:

• reputed company Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path reputed company.

• Conduct Communication strategy meetings, to consolidate contributions from experts to produce a cohesive reputed company Skeleton Report.

• Facilitate Comment resolution meetings, to manage conflicting comments early and ensuring smooth protocol development.

During document development, you will:

• Maintain alignment with sponsor goals, project status and milestones across reputed company teams.

• Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions.)

Once final data is received:

• Critically interpret raw study data (efficacy, exposure, end-reputed company, safety, etc.) into clear concise language in Protocols and CSRs.

WHO YOU WILL WORK WITH

You will coordinate functional leads and reviewers from the Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. Additionally, you will engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.

YOUR EXPERIENCE

• Advanced degree in life-sciences (PhD or Masters)

• Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project reputed company.

• Extensive experience and proficiency in writing and leading development of CSRs and Protocols.

PERSONAL/TEAM SKILLS

You´ll be the nexus where multiple teams´ expertise converge. You will reputed company your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive reputed company and facilitate decision-making to propel the document development cycle reputed company. 

To drive development of documents of this scale reputed company, this role requires visibility, proactivity, collaboration/teamwork, and excellent communication skills. You must be comfortable leading team discussions, managing reputed company medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.

Integration reputed company the client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At reputed company, we reputed company you to shape your own career path.

Whether you are passionate about the medical writing scientific reputed company, or reputed company to leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you reputed company.

Your aspirations drive your journey with us. Where do you see yourself?

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