Synergy Pharm - Senior Medical Writer
Our company is a fast-growing French medical writing company, working for a variety of pharmaceutical companies, Biotechs, and scientific and medical publishing companies
Job title: Scientific /medical writer; reporting to the head of our regulatory medical writing division.
Responsibilities: writing regulatory and clinical documentation (clinical study reports, protocols, common technical documents ICH compliant), and from time to time original manuscripts and review articles for peer-reviewed life-sciences and biomedical journals, or scientific documents for marketing and medical purposes (congresses highlights, slide kits, etc).
Performing quality control i.e., reviewing his/her work or work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements in order to ensure high quality documents are produced.
From time to time managing projects including supervision of subcontractor’s job
Maintaining audit and SOP compliance
Education: PhD degree in life science or biomedical discipline (biochemistry, pharmacology…), a postdoctoral experience is a plus, or MD or PharmD with a significant medical writing work experience.
Desirable professional education credentials (not mandatory): EMWA or AMWA certificates; other regulatory, scientific, or medical writing certificate, certification, or diploma.
Experience and qualifications requirements:
- ≥ 3 years of regulatory medical writing experience, or relevant pharma industry experience combined with scientific and regulatory knowledge, and extensive knowledge of medical writing processes.
- Knowledge of pharmaceutical regulatory environment would be desirable; in particular knowledge of clinical documents such as clinical study reports, study protocols, technical documents at ICH standards etc.
- A good understanding of biostatistics principles, and data interpretation and presentation skills would be a plus.
- Experience in bibliographic searches on Pubmed and writing bibliographic reports
Experience in preparing and editing manuscripts following authors’ instructions and recommendations
- Excellent scientific and general writing skills (Native English, French is a plus)
- Extremely rigorous
- Strong analytical and synthesis skills
- Excellent team spirit, very open minded
- Organized and autonomous, able to work remotely
- Ability to manage various projects, create, work and deliver high-quality publications and documents within timelines, and to do quality control
- Flexibility: ability to question him(her)self, accepting the idea of being reviewed, criticized (constructively), and corrected !
- Proficiency in using Microsoft Word, Excel, Pwp, Endnote, Pubmed
- Experience in process improvement initiatives.
Full time job, home-based
Package: to be discussed depending on experience; freelance collaboration possible
APPLICATION PROCESS: resume + letter to be sent to: firstname.lastname@example.org