Medical Writer

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 a Medical Writer to be part of our medical writing group in Edinburgh. The role will require preparing clinical study reports, protocols and protocol amendments from assigned studies and manage the review and approval ensuring adherence to timelines and quality.
Data Sciences at Quotient Sciences comprises 6 departments (including Medical Writing) and over 100 staff and provides an expert service in the data management, analysis and medical writing of early phase clinical studies
Main tasks and responsibilities
- Act as Lead Medical Writer on assigned studies
- Attend project meetings and data review meetings
- Prepare clinical study reports from assigned studies according to relevant guidelines and Quotient
- or client-specific formats.
- Review reporting and analysis plan and provide input on required tables.
- Create medical writing timelines with project team based on productivity standards and sponsor expectations.
- Work collaboratively with functional contributors to ensure that all information and data are appropriately reported in terms of accuracy and completeness.
- Coordinate compilation of final clinical study reports and appendices.
- Prepare protocols and protocol amendments for assigned studies according to relevant guidelines and Quotient
- or client-specific formats.
- Perform quality control of documents written by other medical writers as requested.
- Coordinate internal and external review of clinical study reports and protocols.
- Arrange transfer of clinical study reports and protocols from assigned studies to sponsors in the required format.
- Maintain organised, complete and up-to-date project documentation including quality control documents in compliance with Quotient and sponsor requirements.
- Review and adhere to the requirements of SOPs, regulatory guidance and directives.
- Maintain awareness of project scope of work and notify senior management of all sponsor requests that are outside the current scope in accordance with relevant SOPs.
- Complete project medical writing activities within the allotted timeframe and ensure that their line manager is kept fully informed of the status of assigned studies.
- Ensure that all tasks comply with department standard operating procedures.
- Maintain awareness of global trends in medical writing.
- Responsible for ensuring that a safe working environment is maintained by observing all safety procedures and working methods, by making proper use of protective clothing and equipment and by reading, understanding and following all safety documents.
- Participate in overtime as is reasonably required to ensure the smooth running of the department.
- To undertake other such tasks as might reasonably be requested from time to time by their supervisor and to ensure that work is conducted in a co-operative and flexible manner.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Working knowledge of clinical data and ICH/Good Clinical Practices is preferred.
- 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
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 organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, colour, 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