Principal Medical Writer - FSP (M/W/D)

Description

The role covers medical writing for clinical documents submitted to regulators worldwide, such as Investigator's Brochures, Clinical Study Reports and marketing authorization submissions.

You set the strategic direction for cross-functional project teams and work with minimal oversight.

You make sure these documents present key clinical data and messages consistently and accurately, in line with program goals and regulatory requirements.

You will write documents yourself or direct and lead other writers, so that deliveries are on time and high quality: scientifically sound, logically structured, and correct in how data is shown and interpreted.

You oversee writing across several compounds and act as lead writer on key summary documents. A broad grasp of clinical research and global document standards is expected.

Responsibilities

• Create regulatory documents for submission to agencies worldwide, following ICH and other global guidelines, standards and processes, the client's authoring standards where they apply, and project timelines and corporate goals.
• Build medical writing timelines with study teams where needed, and keep cross-functional colleagues informed so you stay aware of review cycles and expectations.
• Join cross-functional meetings to advise on writing deliverables, timelines and the processes needed to finish regulatory documents.
• Review related project documents such as protocols and statistical analysis plans where relevant.
• Take part in cross-functional process improvement work.
• Help define and write standard operating procedures and best practices that make document preparation efficient and high quality.
• Direct internal and contract writing resources so assigned projects finish on time.

Requirements

• A bachelor's degree is required. An advanced degree in a relevant scientific, clinical or regulatory field is preferred.
• At least 5 years of medical writing experience in biopharmaceutical or CRO settings is required, or comparable experience in clinical or preclinical development.
• You must be able to organize and communicate clinical information with minimal oversight.
• Strong organization, time management and project management skills are required.
• Strong verbal, written and interpersonal skills are needed to work well within a team.
• A solid grasp of global regulatory requirements is needed. Knowledge of therapeutic areas across all phases of clinical development is desired.

Conditions

The company is the company, a global provider of clinical research services, commercial insights and healthcare intelligence for life sciences and healthcare.

Equal-opportunity note: the company is committed to integrity in hiring and has zero tolerance for candidate fraud; all application information and credentials must be truthful and complete, and any false statement or material omission may lead to disqualification or termination if found later, under applicable law.