- Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, and Investigator's Brochures, integrated summaries, and sections of regulatory submissions) in partnership service providers and cross-functional team members
- Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, analysis plans, data outputs)
- Collaborates with cross-functional team to review study results
- Contributes scientific knowledge and analytical skills to the production of documents
- Participates in developing key messages for routine documents and conduct literature searches
- Develops timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
- Act as a subject matter expert for standard operating procedures applicable to Medical Writing and identifies areas for process improvement.
- Works effectively with an electronic document management system and related tools to develop clinical documents
- Bachelor's degree in relevant discipline, Ph.D. (or equivalent degree)
- Typically requires 5+ years of experience or the equivalent combination of education and experience
- Excellent written and verbal communication skills
- Experience producing high-quality scientific/medical documents
- Ability to analyze, interpret, and summarize data
- Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
- Basic project management and organizational skills
- Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department
- Attention to detail related to consistency, grammar, syntax, and scientific accuracy
- Basic computer skills related to word processing, templates, table/figure creation, and literature searches
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Senior Manager, Medical Writing
2 days ago
Pharma Partners Recruitment Ltd Cambridge, Cambridgeshire, United KingdomSenior Manager Regulatory Affairs Writing · A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies. · ...
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Senior Manager, Medical Writing
2 days ago
Pharma Partners Recruitment Ltd Cambridge, Cambridgeshire, United KingdomSenior Manager Regulatory Affairs WritingA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies. Respons ...
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Clinical Fellow Higher
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Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for the post of Clinical Fellow (Higher ST3 - ST5) in Anaesthetics at this busy major UK teaching hospital. The post is available from the 1 February 2023 for 6 months. · The Clinical Fellow position would suit any trainee with a minimum of two years expe ...
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Consultant in Histopathology
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Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for a Consultant in Histopathology (Renal Pathology) at Addenbrooke's Hospital, part of Cambridge University Hospitals NHS Foundation Trust. · This is a full-time, 10 PA post available as soon as possible. · The primary duty of this post will be reporting ...
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Machine Operator
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The One Group Cambridge, United Kingdom**Production Operator - Pharmaceutical Manufacturing · Cambridge · Nights - Tuesday to Friday OR Sunday to Wednesday · £35,000 - £37,000** · Our client, a worldwide award-winning pharmaceutical producer, are currently going through a huge growth period and have lots of staff to r ...
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Machine Operator
16 hours ago
The One Group Cambridge, United Kingdom**Machine Operator - Pharmaceutical Manufacturing · Cambridge · Days Monday to Friday (6-2 & 2-10 Shift) · £30,000 - £32,000** · Our client, a worldwide award-winning pharmaceutical producer, are currently going through a huge growth period and have lots of staff to recruit · We ...
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Consultant in Histopathology
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Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for a Consultant in Histopathology (Breast & Skin Pathology) at Addenbrooke's Hospital, part of Cambridge University Hospitals NHS Foundation Trust. · This is a full-time, 10 PA post available as soon as possible. · The primary duty of this post will be r ...
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Consultant in Histopathology
16 hours ago
Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for a Consultant in Histopathology (Gastrointestinal & Skin Pathology) at Addenbrooke's Hospital, part of Cambridge University Hospitals NHS Foundation Trust. · This is a full-time, 10 PA post available as soon as possible. · The primary duty of this post ...
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Consultant in Renal Medicine
1 day ago
Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for a full-time NHS Consultant Nephrologist at Addenbrooke's Hospital. This is a new post created due to changes in the roles of two existing colleagues to provide care across the full range of services within nephrology, and to promote innovation and res ...
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Consultant in Dermatopathology
16 hours ago
Cambridge University Hospitals NHS Foundation Trust Cambridge, United KingdomApplications are invited for a Consultant in Dermatopathology at Addenbrooke's Hospital, part of Cambridge University Hospitals NHS Foundation Trust. · This is a full-time, 10 PA post available as soon as possible. · The primary duty of this post will be reporting dermatopatholog ...
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Content Lead
1 day ago
Cambridge University Press & Assessment Cambridge, United Kingdom**Salary**: £32,100 - £38,000 · Location: Cambridge · Contract: Full Time/Fixed Term (12 months) · We are Cambridge University Press & Assessment, a world-leading academic publisher and assessment organisation and a proud part of the University of Cambridge. · Do you have up-to-d ...
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Project Cataloguer
1 day ago
University of Cambridge Cambridge, United KingdomCurious Cures in Cambridge Libraries is a two-year project funded by the Wellcome Trust that will make approximately 8,000 unedited medical recipes in over 180 medieval manuscripts discoverable to researchers worldwide. We are looking for a Project Cataloguer to join the team in ...
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Clinical Fellow
16 hours ago
Cambridge University Hospitals Cambridge, United Kingdom**Main area** · - Obstetrics and Gynaecology**Grade** · - NHS Medical & Dental: Specialty Trainee (ST1/2)**Contract** · - Fixed term: 12 months**Hours** · - Full time - 40 hours per week**Job ref** · - 180-CFC-4749**Employer** · - Cambridge University Hospitals NHS Foundation Tru ...
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Clinical Research Associate
16 hours ago
CMR Surgical Cambridge, United KingdomWe're looking for an exceptional Clinical Research Associate to join our Medical Affairs Team, based in Cambridge. Reporting to our Clinical Research Lead. This position will play a crucial role in providing support to execute clinical trials and data collection for the safety an ...
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Trainee Asbestos Consultant
16 hours ago
S2 Partnership Cambridge, United Kingdom**Please note, this opportunity is NOT open to recruiters.** · **Trainee Asbestos Consultant, Home Based, South East of England, preferably within commuting distance of Cambridge.** · **Our Company** · Join the S2 Partnership to be part of a highly successful business that delive ...
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Customer Service Advisor
1 day ago
Cambridge University Press & Assessment Cambridge, United Kingdom**Salary**: 222,200 - £26,400 · **Location**: Cambridge, UK Hybrid (2 days per working from the office are expected) · **Contract**: 1 Year Fixed Term Contract · For many customers, speaking to a Helpdesk Analyst is their first experience of the organisation, so we need great peo ...
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Technical Programme Manager, Medical
16 hours ago
Sagentia Innovation Harston, United KingdomSagentia's Medical Division works with global, leading companies and disruptive start-ups in a range of healthcare and medical device fields. We help R&D and business development teams to explore market markets and trends, discover enabling technologiesand partners, define and de ...
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Quality Assurance Administrator
16 hours ago
Cranleigh STEM Saffron Walden, United KingdomCranleigh STEM is working with a leading medical device manufacturer on the border of Essex and Cambridgeshire, we are looking for a Quality Assurance Administrator to join its team on a permanent, full-time basis. · As a quality administrator, you will play a key role in managin ...
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Marketing Coordinator
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RAGT Seeds Limited Saffron Walden, United Kingdom**Are you are interested in marketing and communications, agriculture and looking for your next career move?** · We are looking for two experienced Marketing Communications professionals to join our team as the marketing leads for the UK subsidiary of RAGT. The focus of the roles ...
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Administrator
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Country Court Saffron Walden, United Kingdom**Care Home Administrator -Required at The Grange Care Home located in Newport near Saffron Walden -Part of the Country Court Family** · **Hours: Monday to Friday, 37.5 hours per week.** · We are looking for an experienced administrator for our care home 'The Grange', where you w ...
Associate Director, Medical Writing - Cambridge, United Kingdom - Relay Therapeutics
Description
The Medical Writing Lead is responsible for authoring routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study level activities. This role may assist other Medical Writing staff to prepare more complex documents.
Responsibilities:
Qualifications:
Associate Director, Medical Writing professionals in Cambridge
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Vidya Math
Scientific/ Clinical Trials Project Manager
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sampada Ithape
Healthcare professional
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Monica Slabu
Talent Acquisition