- Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safetyupdate/aggregate reports, and integrated summaries of safety and efficacy.
- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. Project Management
- Operate as the project lead writer/submission coordinator and primary client Management contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.
- Develop, coordinate, and oversee work plans for individual and multiple document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives.
- Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Client Liaison/Service
- Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
- Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. Training/Compliance
- Keep abreast of new advances in medical writing and regulatory issues.
- Develop and train Medical Writing Services staff to enhance writingquality, efficiency, and project management.
- Implement and monitor departmental compliance to SOPs. Inputto development or revision of departmental SOPs, as appropriate. General
- Attend departmental and company meetings as necessary.
- Comply with departmental procedures and requirements, such ascompletion of project assignment and workload trackers on the applicablesoftware platform
- Analyze efficiency of work and discuss improvement ideas with Medical WritingServices management and colleagues
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent Skills :
- Excellent interpersonal, negotiation, verbal, and written communication skills.
- A flexible attitude with respect to work assignments and new learning.
- Motivation to work consistently in a fast paced, rapidly changing environment.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.
- Competent working in a matrix environment and values the importance of teamwork.
- Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
- Understands and satisfies client needs.
- Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
- Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Extensive clinical/scientific writing skills acting as either a Senior Medical Writer or PrincipalMedical Writer
- Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
-
Medical Writer
2 weeks ago
Bioscript Group London, United KingdomUnleash Your Passion for Medical Writing at Bioscript Group · Are you an experienced medical wordsmith with a passion for translating complex information into compelling narratives? Elevate your career to the next level with Bioscript Group as a Medical Writer, becoming an integr ...
-
Medical Writer
1 week ago
Cpl Life Sciences London, United Kingdom**Reference Number**: JO · Medical Writer · **Rate**: Negotiable · **Job Type**: Permanent · **Location**: Central London / West End · Medical Writer · Central London · - Positions available in Oxford and Manchester too, full remote working options are also available. · The Medi ...
-
Lead Medical Writer/medical Writer
1 week ago
X4 Group London, United KingdomA CRO is looking to grow a medical writing team for a new 12 month project. If you have 40 hours a week to contribute to a big project then read on · - 12 month contract - possible extension. · - Full time - 40 hours per week. · - Fully remote - available to work from UK/EU. · - ...
-
Medical Writer
4 days ago
Lumanity London, United KingdomOverview / About us: · Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and d ...
-
Associate Medical Writer/medical Writer
1 week ago
ApotheCom London, United KingdomApotheCom, an exciting and innovative leader in the field of medical communications, is growing We are seeking a Medical Writer to join our team in London or Manchester. · Drawn together from various backgrounds including the pharmaceutical industry, research, marketing, medical ...
-
Medical Writer
1 week ago
Synaptiq Health London, United KingdomMedical Writer (Commercial) · Location: London, Hybrid · **Salary**: £35,000 - £40,000 · emotive is a global healthcare communications agency who partner with health-focused companies across medical & scientific affairs, brand & patient engagement and PR & advocacy. Our commitmen ...
-
Medical Writer
2 weeks ago
ApotheCom London, United KingdomMEDiSTRAVA Consulting is part of Inizio, a global healthcare consulting and communications group that supports some of the world's leading life sciences companies by providing a full suite of advisory, medical, marketing, communications, and patient and stakeholder engagement ser ...
-
Medical Writer
1 day ago
Omnicom Health Group London, United KingdomOverview: · **DDB Remedy** · **Medical Writer** · **Reports To · **Senior Medical Writer / Associate Creative Director · **Position Summary · **The Medical Writer's main function is to produce outstanding, medically accurate, technical campaign materials, which reflects the clien ...
-
Medical Writer
5 days ago
Nucleus Global London, United KingdomOffice based - Hybrid - UK Remote · Nucleus Global is part of Inizio, a global healthcare consulting and communications group that supports some of the world's leading life sciences companies by providing a full suite of advisory, medical, marketing, communications, and patient a ...
-
Medical Writer
4 hours ago
Hobson Prior London, United Kingdom**Salary**: · Negotiable**Job type**: · Permanent · **Location**: · London, England · **Function**: · Medical, Medical Communication · **Posted**:31/01/2024 · **Ref**: · BBBH23937 · - Hi I'm · Grant · , I manage this role · Hobson Prior are working closely with a brilliant CRO wh ...
-
Medical Writer
2 days ago
Daniel Laghaney - Healthcare Communications Talent Consultancy London, United Kingdom**Medical Writer** · Are you too busy with your current job, having to work evenings and weekends, and want to change your job, but don't have the time to search, research, and apply? · Leave it to me, Let have a chat and I can do all the leg work for you · I partner with organis ...
-
Medical Writer
1 week ago
Synaptiq Health London, United Kingdomemotive is a global healthcare communications agency who partner with health-focused companies across medical & scientific affairs, brand & patient engagement and PR & advocacy. Our commitment to our core values of **IMAGINATION**, **COLLABORATION**, **EMPOWERMENT**, **INTEGRITY ...
-
Medical Writer
1 week ago
MEDiSTRAVA London, United KingdomMEDiSTRAVA is part of Inizio, a global healthcare consulting and communications group that supports some of the world's leading life sciences companies by providing a full suite of advisory, medical, marketing, communications, and patient and stakeholder engagement services. With ...
-
Medical Writer
2 weeks ago
Syneos Health Clinical London, United Kingdom**Overview** · **Can you reach people with just a few words?** · You express all of your ideas effortlessly, and have the skills to distill other people's ideas into their best possible form. Your messaging is not only clear and concise, but your medical expertise allows you to c ...
-
Medical Writer
2 weeks ago
Syneos Health Commercial Solutions London, United Kingdom**Overview** · **Can you reach people with just a few words?** · You express all of your ideas effortlessly, and have the skills to distill other people's ideas into their best possible form. Your messaging is not only clear and concise, but your medical expertise allows you to c ...
-
Medical Writer
1 week ago
Virgo Health London, United Kingdom**About us**: · Virgo Health is a specialist health communications agency, part of the GOLIN group and the wider IPG network of companies with more than 200 offices around the world as well as hubs in London, New York and Chicago. · The Health Education team is a specialist divis ...
-
Medical Writer
1 week ago
Envision Pharma Group London, United KingdomAt 90TEN we make people healthier and happier through life changing communications and medical education. · **Who we are** · 90TEN has more than 70 employees, dedicated PR and medical education divisions and is recognised as one of the leading healthcare communications consultanc ...
-
Medical Writer
2 weeks ago
Nucleus Global London, United KingdomSciMentum is an international medical communications agency. Our reputation for delivering high-quality and creative communication solutions is founded on the scientific expertise, strategic understanding and motivation of our staff. As part of Nucleus Global, our clients benefit ...
-
Medical Writer
1 week ago
Mtech Access London, United Kingdom**About us** · We are a dynamic, friendly, and rapidly expanding independent market access and HEOR consultancy with offices in Oxfordshire, London, Manchester, York, Newcastle, and Cambridge. We provide strategy and solutions to help Pharma and Medtech companies bring interventi ...
-
Medical Writer
4 hours ago
OPEN Health London, United KingdomReports to Director of Scientific Services · **Essential Duties & Responsibilities** · - Working in an account management team, alongside Medical Writers and a creative team, to manage our clients' requirements and deliver their projects · - Taking full ownership of the communica ...
Senior Medical Writer - United Kingdom - Parexel
Description
Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.
From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.We looking for a Senior Medical Writer's due to an ever expanding team. These roles can be fully home based in various European countries. As the Principal Medical Writer you will research, create, and edit all documents associated withclinical research. You will operate as the project lead writer/submission coordinatorand primary client contact to manage contributions of multiple writers working on related documents. You will alsofacilitate process improvement and technical mentoring/training and supportMedical Writing Services management during the sales process by providing client liaison and proposalsinput.
Key Accountabilities:
Author Clinical Documents
- Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
Knowledge and Experience: