Principal Regulatory Medical Writer
1 semana atrás
We are the people of PPD clinical research services part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Principal Regulatory Medical Writer (home based)
As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
You will be a part of a team who is dedicated to its people and fosters a supportive, collaborative culture based on trust, flexibility and work-life balance.
You would be able to consider the work setting where you would be most productive, able to choose being entirely remote based or work part-time of at least 25-30hours per week.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.
Summarized Purpose:
Essential Functions:
- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various clientspecific processes.
- May assist in program management activities. Identifies and resolves outofscope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Experience within regulatory medical writing (comparable to 8+ years).
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills and Abilities:
- Significant knowledge of global, regional, national and other document development guidelines
- Indepth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead junior level staff
What we offer
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team.
We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.
We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.
We are a global organization but with a local feel.Our 4i Values:
**Integrity - Innovation - Intensity - Involvement
-
Principal Medical Writer- Regulatory
1 semana atrás
Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroUpdated: May 10, 2024Location: Portugal-Europe - PRT-Home-BasedJob ID: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the...
-
Medical Writer
1 semana atrás
Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiroCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Manager Regulatory Medical Writing, Oncology
1 semana atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJob Description - Manager Regulatory Medical Writing, Oncology W) Manager Regulatory Medical Writing, Oncology W Description Manager Regulatory Medical Writing, OncologyAt Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and...
-
Manager Regulatory Medical Writing, Oncology
1 semana atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJob Description - Manager Regulatory Medical Writing, Oncology W) Manager Regulatory Medical Writing, Oncology W Description Manager Regulatory Medical Writing, Oncology At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and...
-
Associate Principal Scientist, Regulatory
1 semana atrás
Lisboa, Lisboa, Portugal Organon Tempo inteiroReporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...
-
Principal Medical Writer
1 semana atrás
Lisboa, Lisboa, Portugal Mygwork - Lgbtq+ Business Community Tempo inteiroAssociate Scientist Monday-Thursday 3PM 1AMBiotechnologyJob DescriptionJob: Entry Level ChemisShift: 4 day x 10 hoursMonday-Thursday 3 PM 1 AMDepartment: Small Molecule/Physical Chemistry and Character...Location Middleton, Wisconsin, United StatesLatam FP&A Analyst IIBiotechnologyJob DescriptionWhen you're part of the team at Thermo Fisher Scientific,...
-
Lisboa, Lisboa, Portugal Organon Tempo inteiroAssociate Principal Scientist, Regulatory Chemistry, Manufacturing and Control Product Lead Lisboa Associate Principal Scientist, Regulatory Chemistry, Manufacturing and ControlProduct LeadLisboa Lisboa, Lisboa, Portugal Job Description The Position The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for...
-
Internship: Regulatory Affairs
2 meses atrás
Lisboa, Lisboa, Portugal Philips Tempo inteiroJob TitleInternship: Regulatory Affairs & Compliance InternJob DescriptionLocation: LisbonWorking time: 39 hours/weekStart date: as soon as possibleType: 1-year, remunerated internshipYour role:Maintaining Expertise: Continuously enhance personal competencies, scientific knowledge, and technical skills in specific sections of the technical documentation of...
-
Internship: Regulatory Affairs
3 semanas atrás
Lisboa, Lisboa, Portugal Philips Tempo inteiroJob TitleInternship: Regulatory Affairs & Compliance InternJob DescriptionLocation: LisbonWorking time: 39 hours/weekStart date: as soon as possibleType: 1-year, remunerated internshipYour role:Maintaining Expertise: Continuously enhance personal competencies, scientific knowledge, and technical skills in specific sections of the technical documentation of...
-
Medical Lead
1 semana atrás
Lisboa, Lisboa, Portugal Viatris Tempo inteiro1422 Mylan, Lda.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines regardless of geography or...
-
Internship: Regulatory Affairs
1 semana atrás
Lisboa, Lisboa, Portugal Philips Tempo inteiroJob Title: Internship: Regulatory Affairs & Compliance InternLocation:LisbonWorking time:39 hours/weekStart date:as soon as possibleType:1-year, remunerated internshipYour role:- Maintaining Expertise: Continuously enhance personal competencies, scientific knowledge, and technical skills in specific sections of the technical documentation of Medical Devices...
-
Regulatory Affairs Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Kenvue Tempo inteiroRegulatory Affairs Specialist WDescriptionAt Kenvue, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID —are category leaders trusted by millions of consumers who use our products to...
-
Principal Quality Systems Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Hovione Tempo inteiroJoin a Market Leader:Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical...
-
Medical Affairs Manager
1 semana atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroFor our pharmaceutical sector, we are currently recruiting a Medical Affairs Manager (M/F) - Immunology on a permanent contract. The role is based in our Lisbon office.OVERALL PURPOSE OF THE JOB:To plan, coordinate, and execute Medical Affairs Plan, including research and publication programs conducted by Medical Affairs.To be a therapeutic area scientific...
-
Medical Affairs Manager
1 semana atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJob Description - Medical Affairs Manager (M/F) - Immunology W) Medical Affairs Manager (M/F) - Immunology W Description At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,...
-
Senior Associate Regulatory Affairs
1 semana atrás
Lisboa, Lisboa, Portugal Grabjobs Portugal Tempo inteiroSenior Associate Regulatory Affairs page is loaded Senior Associate Regulatory Affairs Apply remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will...
-
Trainee Medical
1 semana atrás
Lisboa, Lisboa, Portugal LEO Pharma Tempo inteiroField of work:Regulatory & MedicalPosting Date:01-Jun-2023Application deadline: 20-Jun-2023Location: Lisbon, , PortugalContract type: PermanentJob ID: 1178- For more than 80 years, LEO Pharma has been committed to helping people suffering from thrombosis. Each one of us at LEO Pharma can make a real impact in our everyday work as we strive to deliver the...
-
Medical Cannabis Grower
Há 1 mês
Lisboa, Lisboa, Portugal Batherafarm, Unipessoal, Lda Tempo inteiroThe Grower will be responsible for overseeing the cultivation of medical cannabis from seed to harvest. This role is essential for maintaining the health, quality, and productivity of our cannabis plants while ensuring compliance with regulatory standards.Key Responsibilities:Manage all aspects of the cultivation process, including planting, watering,...
-
Medical Cannabis Grower
3 semanas atrás
Lisboa, Lisboa, Portugal Batherafarm, Unipessoal, Lda Tempo inteiroThe Grower will be responsible for overseeing the cultivation of medical cannabis from seed to harvest. This role is essential for maintaining the health, quality, and productivity of our cannabis plants while ensuring compliance with regulatory standards.Key Responsibilities:Manage all aspects of the cultivation process, including planting, watering,...
-
Medical Liaison Manager
1 semana atrás
Lisboa, Lisboa, Portugal Biogen Tempo inteiroJob Description About this role**The main purpose of this position is meeting patients' individual needs, through the following activities and responsibilities, to be carried out in his/her country: Provide fieldbased medical / scientific expertise ensuring understanding of the disease areas and Biogen's products as appropriate. Build valued constructive...