-
Rare Disease Research Partners Amersham, United KingdomWe are looking for a talented medical writer to join our small bespoke medical communications and research agency that specialises in rare and complex diseases. If you have a passion for writing, a keen eye for detail and can translate research findings into accurate and engaging ...
-
Senior Manager of Medical Writing
2 weeks ago
Jazz Pharmaceuticals Oxford, Oxfordshire, United KingdomJazz Pharmaceuticals plc (NASDAQ: We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage deve ...
-
Senior Manager of Medical Writing
4 days ago
Jazz Pharmaceutical Oxford, Oxfordshire, United KingdomIf you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed m ...
-
Senior Manager of Medical Writing
2 weeks ago
Jazz Pharmaceuticals Oxford, Oxfordshire, United KingdomIf you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed m ...
-
Medical Writing Manager
2 weeks ago
Baxter Healthcare Newbury, Berkshire, United KingdomAt Baxter, we are deeply connected by our mission. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. · The Manager, Medical Inf ...
-
Medical Writing Editor I
1 week ago
Fortrea Maidenhead, Berkshire, United KingdomAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
-
Associate Director Medical Writing
4 days ago
Johnson & Johnson High Wycombe, United Kingdom Full timeAssociate Director, Medical Writing · Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Medical Writing . The primary location for this position is the United Kingdom. Secondary locations are Canada, ...
-
Software Development Engineer
1 week ago
Cpl Life Sciences Oxford, United KingdomSoftware Development Engineer / Applications C++ Engineer required to work for a high Tech Medical Device company based in Oxfordshire. · As the Software Development Engineer you will Design and develop software modules/systems in accordance with appropriate software specificatio ...
-
Medical Retina Fellow Aug 23
1 week ago
Oxford University Hospitals NHS Foundation Trust Oxford, United KingdomOXFORD UNIVERSITY HOSPITALS NHS TRUST · MEDICAL RETINA FELLOWSHIP · Applications are invited for the MR fellowships in Ophthalmology based at the John Radcliffe Hospital Oxford, from August 2023 for 12 months in the first instance. · The Oxford Eye Hospital and its consultant bod ...
-
Full Time Clinic Co-ordinator
1 hour ago
The Dermatology Partnership Oxford, United Kingdom Full time* · Role responsibilities* · - Welcoming patients to the clinic · - Booking appointments · - Processing payments and reconciling the till · - Preparing clinic files, scanning, uploading, data input to the systems · - Liaising with other doctors/ GPs/ other clinics to ensure a smo ...
-
Regulatory Affairs Specialist
22 hours ago
Adaptix Oxford, United Kingdom**Description**: · **Want to be part of a team transforming healthcare?** · We are looking for an experienced · **Regulatory Affairs Specialist **to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Working within the Quality and Reg ...
-
Medical Writer
1 week ago
Highfield Communication Oxford, United Kingdom**_This job role outlines the minimum tasks and competencies that are expected to be demonstrated within the role. In line with our values we encourage proactivity and innovation within all roles._** · **Reports to** · Senior Medical Writer/Editorial Director · **Job overview** · ...
-
Qualitative Researcher
1 week ago
University of Oxford Oxford, United KingdomApplications are invited for a Qualitative Researcher to join a team working with Dr Rebecca Barnes and Professor Richard McManus researching the real world implementation of two different primary care interventions: a system of self-monitoring of blood pressure for people with h ...
-
University of Oxford Oxford, United KingdomWe have an exciting opportunity for a Research Assistant in Epidemiology and Health Data Sciences to join the Pharmaco · - and Device epidemiology research group led by Professor Daniel Prieto-Alhambra at the Botnar Research Centre, NDORMS, University of Oxford. The NDORMS Pharma ...
-
Teaching Fellow
1 hour ago
University of Oxford Oxford, United KingdomApplications are invited for a Teaching Fellow, to work with the Centre for Evidence-Based Medicine and Professor Carl Heneghan on teaching Evidence-Based Medicine in the Oxford Medical School curriculum. · Medicine mapping to the Outcomes for Graduates (Tomorrow's Doctors), upda ...
-
Clinical Recruitment Advisor
1 week ago
Venn Group Oxfordshire, United Kingdom**Clinical Recruitment Advisor** · **Agency Reference: J67018** · Venn Group are delighted to have once again partnered with one of our valued clients in the Health sector, to source a proactive and diligent recruitment professional for the following interim assignment: · **Locat ...
-
Technical Document Administrator
3 days ago
Bond Williams Limited Oxford, United Kingdom Full timeAn innovative Medical Device company in Oxford (OX4) are seeking a Technical Documentation Administrator to provide essential day-to-day support in managing and maintaining design history files and associated records. Reporting directly to the Design Control Manager, your primary ...
-
Veterinary Care Assistant
2 days ago
Medivet Group Ltd Oxford, United Kingdom**About us** · **The role** · As a Veterinary Care Assistant, you will be an integral part of the practice team and will perform a variety of duties, such as: · - Working with our veterinary surgeons, qualified nurses, and student nurses to provide exceptional care to our patient ...
-
Medical Writer
2 days ago
Albion Rye Associates Oxford, United Kingdom**Medical Writer - Medical Education** · **Oxford or Manchester - Hybrid working** · **Upwards of £35,000 DOE** · Albion Rye Associates are delighted to be partnering with a thriving independent medical communications agency on the search for a Medical Writer to join their award- ...
-
Communications Officer
1 week ago
University of Oxford Oxford, United Kingdom**About the role** · We have an exciting opportunity to join the Department of Paediatrics as our Communications Officer. · You will be responsible for information-sharing across the department, and raising awareness of the aims and achievements of the department both internally ...
Associate Director, Regulatory Medical Writing - Oxford, Oxfordshire, United Kingdom - Moderna Therapeutics Inc.
Description
As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is expanding its innovative reach in Harwell, UK, a leading center for scientific research and development. Our state-of-the-art manufacturing site here plays a critical role in advancing our mission of delivering mRNA medicines globally. We invite committed professionals to join our Harwell team and contribute to groundbreaking medical advancements.A position of great responsibility and impact, the Associate Director for Quality Control at our Harwell manufacturing site is crucial in overseeing the commercial testing functions within the Quality Control department.
This role supports raw materials and drug substances testing for mRNA products, encompassing Microbiological and Environmental Monitoring (EM) tests, and extends to method transfer, qualification, and validation activities.
Gain a comprehensive understanding of Moderna's Quality Control processes and standards, specifically focusing on the nuances of commercial testing functions for mRNA products.
This includes familiarization with testing procedures for raw materials, drug substances, Microbiological and EM tests.Begin actively overseeing the daily operations of the Quality Control commercial program.
This will involve directly managing functions related to stability testing, ensuring that all testing is conducted in line with Moderna's high standards and regulatory compliance.
Start leading the Quality Control laboratory team, getting to know each team member, their specific roles, and functions. Implement Lean methodologies within the Quality Control department.This will involve analyzing current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.
Take a lead role in the development and updating of Standard Operating Procedures (SOPs) and laboratory data collection & documentation systems, both paper and electronic.
Begin extensive collaboration with other critical departments, including Analytical Sciences & Technology (AS&T), Global QC, External QC, Quality Assurance, and Regulatory Affairs.
These collaborations will focus on supporting drug substance and product testing both internally and at Contract Manufacturing Organizations (CMOs), as well as other quality-related information for stability programs and Annual Product Quality Reviews (APQR).
Become fully integrated into your role, leading the Quality Control team with effectiveness and confidence.This will involve ongoing management and mentoring of laboratory personnel, fostering their career development and ensuring the team is meeting all performance and quality targets.
Play a pivotal role in overseeing and managing laboratory investigations, change controls, and Corrective and Preventative Actions (CAPAs) related to Quality Control operations.
This includes ensuring all QC operations are compliant with relevant regulatory and company standards.This will involve overseeing the transfer of new methods into the QC laboratory, ensuring all methods are robust, validated, and fit for purpose.
This includes interfacing with health authorities during site and external inspections, ensuring that the QC department adheres to all relevant FDA, EU, ICH guidelines, and regulations, and demonstrating Moderna's commitment to maintaining high-quality standards in all operations.
Bachelor's Degree in a relevant scientific discipline.4-6 years of management/supervisory experience.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.
Previous supervisory experience is preferred, including testing scheduling and lab project management.
Minimum knowledge required:
general laboratory operations, method acquisition, qualification.
Technical writing.
Proficiency with Microsoft Office Programs.
Familiarity with electronic databases (e.g., LIMS, SAP, LMS).
Familiarity with QC operations including bioassay, chemistry, and microbiology.
HPLC Instrumentation/ Software experience is preferred.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at .
