Principal Regulatory Medical Writer

Job title:

Principal Regulatory Medical Author

Firm

Most cancers Analysis UK

Job description

4,000 professionals, 0 days wasted, 1 unimaginable objective. Collectively, we’re beating most cancers.Principal Regulatory Medical Author – Centre for Drug ImprovementWage: £50,000 – £58,000 pa + advantagesContract kind/ hours: Everlasting/ full time 35 hours (versatile working requests thought-about)Location: Stratford, London (Excessive flex – we’d count on you to be within the workplace 1 or 2 days per week) or Residence-based UK.Utility Deadline: Wednesday seventeenth April at 23.55. This emptiness could shut earlier if a excessive variety of functions are acquired or as soon as an acceptable candidate is discovered, so please don’t delay submitting your software to keep away from any disappointment.At Most cancers Analysis UK, we exist to beat most cancers.We’re professionals with objective, beating most cancers every single day. However we have to go a lot additional and far quicker. That’s why we we’re in search of somebody proficient, somebody modern and impressive, somebody such as you.Concerning the groupThe Most cancers Analysis UK Centre for Drug Improvement (CDD) is the world’s solely charity-funded drug improvement facility. Our pioneering analysis is pushed purely by the aim to see scientific breakthroughs convey advantages to sufferers sooner.CDD is the sponsor of early part and precision drugs medical trials in oncology brokers. Our broad portfolio rivals that of a medium-sized pharmaceutical firm, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an attention-grabbing and dynamic space to work in.What is going to I be doing?You’ll present medical writing experience for the manufacturing of Medical Research Studies (CSRs), Investigator’s Brochures (IBs) and different medical/scientific studies throughout the Most cancers Analysis UK CDD. You’ll present specialist steerage and recommendation to others and promote finest follow in medical writing, together with figuring out enhancements and making certain consistency. You’ll additionally deputise for the Medical Writing Supervisor when required.Key duties embody to:Be a subject knowledgeable in Medical Writing actions, chargeable for Medical Author coaching and course of enhancements.Act as a mentor and practice new starters and extra junior Medical Writing roles and key teams in CDD as required, sharing information and experience to profit others.Deputise for the Medical Writing Supervisor on delegated duties and characterize the Medical Writing group on cross-functional working teams.Present specialist medical writing expertise inside CDD, together with writing, enhancing, reviewing and high quality management, to make sure well timed manufacturing of CSRs and IBs inside relevant regulatory timeframes.Handle the preparation, replace and monitoring of CSRs, medical trial abstract outcomes and IB Packages in use in CDD‑sponsored trials in keeping with present laws, and compile compliance metrics.Proactively contribute to the continual assessment and enchancment of doc writing processes in CDD, to make sure consistency and finest follow.Produce and preserve applicable regulatory doc templates, SOPs and steerage paperwork.Develop and preserve an consciousness of CDD medical trials and key initiatives. Construct good working relationships with key features in CDD to make sure well timed supply of knowledge and paperwork and to assessment third-party paperwork to evaluate the necessity for IB dietary supplements.Help with recruitment and will have line administration tasks for as much as 2 members of the Medical Writing group.What expertise are we in search of?ImportantScience graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy).In depth regulatory writing expertise with medical trial paperwork together with CSRs and IBs. Would ideally additionally embody expertise working with Protocols, Improvement Security Replace Studies (DSURs).Capability to supply top quality, scientifically/medically correct studies.Expertise reviewing and high quality checking the work of different Medical Writers to make sure they meet the challenge temporary/specification and are scientifically and technically correct.Wonderful proofreading expertise and a spotlight to element.Organisational and communication expertise.Negotiation and influencing expertise.Wonderful written and spoken English.FascinatingMedical/Medical Sciences background or expertise.Larger diploma (Masters or PhD).Expertise in early part medical improvement.Oncology expertise.Mission administration expertise.What is going to I acquire?Every considered one of our staff contributes to our progress and is supporting our work to beat most cancers. We predict that’s spectacular.In return, we be sure to are supported by a beneficiant advantages bundle, a variety of profession and private improvement alternatives and high-quality instruments, insurance policies and processes to allow you to do your job nicely.Our advantages bundle features a substantial retirement plan, a beneficiant and versatile depart allowance, reductions on something from journey to expertise, health club membership, and rather more.We assessment pay yearly and goal to recognise particular person efficiency and achievements.We don’t overlook folks have lives outdoors of labor too and so we actively encourage a versatile working tradition.Our work – from funding cutting-edge analysis to creating public coverage – will change the world. It’s thrilling to be a part of our group.How do I apply?We function an anonymised shortlisting course of in our dedication to equality, range and inclusion. CVs are required for all functions; however we gained’t be capable to view them till we invite you for an interview. As a substitute, we ask you to finish the work historical past part of the web software type for us to have the ability to assess you rapidly, pretty and objectively.For extra updates on our work and careers, comply with us on: Linked In, Fb, Instagram, Twitter and YouTube.There’s a spot for everybody at Most cancers Analysis UK. Our imaginative and prescient is to create a charity the place everybody looks like they belong, advantages from and participates in, the work we do. We’re dedicated to creating an inclusive tradition the place everybody may be themselves and attain their full potential.We actively encourage functions from folks of all backgrounds and cultures, specifically these from ethnic minority backgrounds who’re presently under-represented, and consider {that a} numerous workforce will assist us to beat most cancers sooner.For those who’re serious about making use of and enthusiastic about working with us however are uncertain if in case you have the appropriate expertise and expertise we’d nonetheless love to listen to from you. We don’t count on everybody to satisfy the entire standards listed.We wish to see each candidate acting at their finest all through the job software course of, interview course of and while at work. We due to this fact ask you to tell us of any issues you’ve gotten or any changes you would possibly must allow this to occur by emailing us at .Sadly, we’re unable to recruit anybody beneath the age of 18, in order that we will shield younger folks from well being & security and safeguarding dangers.

Anticipated wage

£50000 – 58000 per yr

Location

England

Job date

Fri, 05 Apr 2024 01:49:12 GMT

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