Medical Writer

Quotient Sciences; City of Edinburgh; Hybrid; GBP 35,000 - 55,000; Full time

Job description

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role
We are looking for an experienced Medical Writer to be part of our medical writing group in Edinburgh. The role could be remote-based for the right candidate. The role will require preparing clinical study reports, protocols, protocol amendments and informed consent forms for assigned studies, and manage their review and approval ensuring adherence to timelines, quality and accuracy.

Main Tasks And Responsibilities

1. Prepare high quality regulatory documentation including protocols, informed consent forms and clinical study reports for assigned studies.
2. Coordinate internal and external review of clinical study reports, informed consent forms and protocols.
3. Adherence to relevant guidelines and Quotient Sciences- or client-specific formats.
4. Completion of medical writing documents according to timelines, budget and client expectations.
5. Perform quality control and peer review of documents written by other medical writers.
6. Act as Lead Medical Writer on assigned studies.
7. Work collaboratively with functional contributors to ensure that all information and data are appropriately reported in terms of accuracy and completeness.
8. Attend internal and external project and data review meetings.
9. Review reporting and analysis plans and provide input on required data presentations.

The Candidate

1. The successful candidate will be degree educated or higher in health, science or related discipline.
2. Minimum of 2 years of experience of writing regulatory documents.
3. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
4. Effective oral and written communication skills, presentation skills, and attention to detail. Proficiency in Word, Excel and Email.
5. Working knowledge of clinical data and ICH/Good Clinical Practices.
6. Ability to multi-task, and work as part of a multi-disciplinary team as well as independently. Ability to be flexible and adapt to change.

Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.