Job Description

Sponsor-dedicated. Full time. Remote in the UK, Greece, Spain or Portugal.

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


But we cant do it alone.


We are seeking an experienced

Senior Regulatory Medical Writer

to lead 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 Fortrea. Your job matters.

WHAT YOU WILL DO

====================


Embedded in the team of one of the worlds 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.


Well trust you to spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor.


From the variety of documents you will work on (Investigators 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:

Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward.
Conduct Communication strategy meetings, to consolidate contributions from experts to produce a cohesive Shell 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 all 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-point, 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.


LOCATIONS


This is a

full-time

,

permanent

job.


Our ideal locations are:

UK, Spain, Portugal

and

Greece

.

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 lead

.
Extensive experience and proficiency in writing and leading development of

CSRs

and

Protocols

.

PERSONAL/TEAM SKILLS

========================


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


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


Integration within the clients team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

=============================


At Fortrea, we empower you to shape your own career path.


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


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


#LI-Remote


#LI-CV1


Learn more about our EEO & Accommodations request here.