Principal Medical Writing Consultant
vor 3 Wochen
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients.
The role will be offered on a contract basis and require approximately a 20 hour commitment per week. There is potential opportunity for this role to progress to full time hours over time. We are looking for candidates based in the UK or EU but the role can be offered on a remote basis.
Ideally candidates will have early phase experience within either Neurology or Oncology.
Essential Functions:
Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable. Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) as assigned. Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned. Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3 or E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. Independently manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).Necessary Skills & Abilities
Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities.Educational and Experience Requirements
Bachelor’s degree or higher, preferably in medical or scientific discipline. Extensive experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
-
Agile Senior Principal Consultant
vor 3 Wochen
Berlin, Deutschland Cavendish Professionals VollzeitAgile Senior Principal Consultant (m/w/d)Wir sind auf der Suche nach einem neuen dynamischen und motivierten Agile Transformation - Senior Principal Consultant (m/w/d), für einen unserer größten globalen IT-Dienstleister mit Sitz in Deutschland.Als Agile Transformation Profis, Sie werden mit großen, weltweit tätigen Unternehmen zusammenarbeiten, um...
-
Principal Consultant
vor 3 Wochen
Berlin, Deutschland AENEAS Group VollzeitAENEAS ist ein spezialisiertes und mehrfach ausgezeichnetes Boutique-Personaldienstleistungsunternehmen für Fach- und Führungskräfte in den Bereichen Finance sowie Office & Administration. An den Standorten Berlin und Köln verbinden wir nationale und internationale Kundenunternehmen mit qualifizierten Mitarbeitenden und bringen dabei...
-
Berlin, Deutschland Medacs Healthcare VollzeitWe are currently seeking experienced Medical Consultants to join our esteemed client—one of the largest and most prestigious healthcare providers in Saudi Arabia.If you are passionate about making a difference in patient care and contributing to cutting-edge medical practices, we invite you to explore the following opportunities:Consultant...
-
Medical Editor
vor 1 Woche
Berlin, Deutschland Maximon Vollzeit**About us** Founded in 2022, Frieda is committed to revolutionizing women's health with a primary focus on addressing menopause-related symptoms. In a world where health meets technology, Frieda emerges as a pioneering force, devoted to transforming the menopause journey into a seamless, empowering, and informed experience. **The role** As a **Medical...
-
Berlin, Deutschland cbs Corporate Business Solutions Unternehmensberatung GmbH VollzeitSenior / Principal Consultant SAP S/4HANA Service (m/w/d) Locations: Berlin, Leipzig, Heidelberg, München, Hamburg, Stuttgart, Dortmund, Freiburg im Breisgau, Rhein-Main (Raunheim) Wir sind die Berater der Weltmarktführer: Hochmotivierte Expertinnen und Experten, die als erfolgreiches Team digitale End-to-End-Geschäftsprozesslösungen vorantreiben....
-
Medical Expert
vor 1 Woche
Berlin, Deutschland Daniel J Edelman Holdings VollzeitThis position can be filled at different locations: Frankfurt am Main; Hamburg; Cologne; Berlin; MunichWe are looking for a Medical Expert (m/f/d).Your tasksSupport in the creation of medical content concepts and advice on medical content strategies in a national and international environmentAnalyzes and strategic derivation of complex medical-scientific...
-
Berlin, Deutschland HRpepper GmbH & Co. KGaA VollzeitWarum wir? HRpepper transformiert Organisationen wirkungsvoll. Und das mit langjähriger Erfahrung, wissenschaftlichen Erkenntnissen und menschenzentrierten Methoden. Mit unserem Handeln leisten wir einen Beitrag, die Arbeitswelt(en) humaner und dadurch nachhaltiger zu gestalten. Wir verstärken unsere Consulting Practice Enable Development & Leadership und...
-
Berlin, Deutschland HRpepper GmbH & Co. KGaA VollzeitWarum wir? HRpepper transformiert Organisationen wirkungsvoll. Und das mit langjähriger Erfahrung, wissenschaftlichen Erkenntnissen und menschenzentrierten Methoden. Mit unserem Handeln leisten wir einen Beitrag, die Arbeitswelt(en) humaner und dadurch nachhaltiger zu gestalten. Wir verstärken unsere Consulting Practice Enable Development & Leadership und...
-
Principal Consultant
vor 17 Stunden
Berlin, Deutschland ITL Germany VollzeitJob Description Today, the corporate landscape is dynamic and the world ahead is full of possibilities! None of the amazing things we do at Infosys would be possible without an equally amazing culture, the environment where ideas can flourish and where you are empowered to move forward as far as your ideas will take you.At Infosys, we assure that your...
-
Principal Consultant PLM
vor 3 Wochen
Berlin, Deutschland ITC Infotech DxP Services VollzeitPTC und ITC Infotech verstärken ihre mehr als 20-jährige Allianz, um Kundeninitiativen zur digitalen Transformation zu beschleunigen. ITC Infotech hat hierzu den neuen Geschäftsbereich DxP Services gegründet und viele PLM-Experten und die Implementierungsdienstleistungen von PTC übernommen. Der Fokus von DxP Services ist die Einführung und der Ausbau...
-
Berlin, Deutschland HRpepper GmbH & Co. KGaA VollzeitWarum wir?HRpepper transformiert Organisationen wirkungsvoll. Und das mit langjähriger Erfahrung, wissenschaftlichen Erkenntnissen und menschenzentrierten Methoden. Mit unserem Handeln leisten wir einen Beitrag, die Arbeitswelt(en) humaner und dadurch nachhaltiger zu gestalten. Wir verstärken unsere Consulting Practice Enable Development & Leadership und...
-
Multilingual Medical Information Specialist
Vor 4 Tagen
Berlin, Deutschland ProPharma Group VollzeitFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Assistent (M/w/d) Im Marketing - Content Writing
Vor 7 Tagen
Berlin, Deutschland MHC Vollzeit**Innovativ, dynamisch, kreativ - das sind wir!** Bei der Medical Hair Company dreht sich alles um Kommunikation und Marketing. Wir planen, koordinieren und analysieren Marketingkampagnen, entwickeln Werbekonzepte und Content-Strategien, produzieren Inhalte und steuern Social-Media-Aktivitäten rund um das Thema Medizintourismus speziell auf dem Gebiet der...
-
Medical Director
vor 4 Wochen
Berlin, Deutschland atai Vollzeit**Contract Duration**: 12 months **Work Hours**: 40 hours/week **Position Type**: Fixed-term contract **Location**:DE / UK The Medical Director/Senior Director is responsible for working cross-functionally to oversee/co-lead the design and development of Phase 1-3 clinical trials. The Clinical Development Director must be highly innovative and take bold...
-
Berlin, Deutschland MHC Vollzeit**Innovativ, dynamisch, kreativ - das sind wir!** Bei der Medical Hair Company dreht sich alles um Kommunikation und Marketing. Wir planen, koordinieren und analysieren Marketingkampagnen, entwickeln Werbekonzepte und Content-Strategien, produzieren Inhalte und steuern Social-Media-Aktivitäten rund um das Thema Medizintourismus speziell auf dem Gebiet der...
-
Principal Copywriter
Vor 4 Tagen
Berlin, Deutschland Pipedrive VollzeitWe believe it takes great people to create a great product. That’s why our team lives our company values, and we hire based on them, too. Since 2010, Pipedrive has been on a mission to support sales and marketing teams with easy-to-use, powerful tools that make everyday work faster and easier. Today, our cloud-based software is trusted by over 100,000...
-
Multilingual Medical Information Specialist Sal
vor 4 Wochen
Berlin, Deutschland ProPharma Group VollzeitFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Remote Consultant Finance
Vor 6 Tagen
Berlin, Deutschland PrimePeople GmbH VollzeitPrincipal Consultant Dynamics 365 Finance & Supply Chain mit Fokus Finance bei europäischem Marktführer (all gender) Holistic Delivery von Microsoft Cloud-Solutions hat unseren Mandanten zu einem der großen Dienstleister auf dem europäischen Markt gemacht. 000 Kolleg*en, um Business Applications, Cloud Infrastructure, Data & Analytics und Modern...
-
Principal Accounting
vor 4 Wochen
Berlin, Deutschland torq.partners GmbH Vollzeit**ÜBER TORQ.PARTNERS**: **Wenn du schnell gehen willst, dann gehe alleine.** **Wenn du weit gehen willst,** **dann musst du mit anderen zusammen gehen.** Afrikanisches Sprichwort Unser holistischer Beratungsansatz hat die praktische Umsetzung im Zentrum, damit Organisationen skalierbar werden: Wir schaffen robuste, agile Strukturen und Prozesse für...
-
Principal Consultant
vor 3 Wochen
Berlin, Deutschland Sphera VollzeitWe are seeking a talented, motivated and passionate environmental sustainability individual to join our Life Cycle Assessment (LCA) team. The primary function of this role is to conduct and manage projects on a variety of challenging assignments related to environmental Life Cycle Assessment modelling and reporting, with particular focus on a variety of...
