Are you looking for the next challenge in your career?
Would you like to be part of an exciting highly qualified team of professionals in an international environment?
We are currently looking for a qualified Medical Writer to join our Life Science/CRO division.
Join Alten’s international division and work alongside with some of the most talented engineers and technicians from all over the world.
Your benefits:
- Competitive Salary.
- Long– term secure contract.
- International Project with top technologies
- Possibility of working remotely with a flexible schedule.
- Integration in a highly qualified team of professionals.
- Travel abroad with your project.
- Specialized training and continuous professional development.
- Social benefits and flexible compensation plan.
Responsibilities:
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develops or supports a variety of documents that include but not limited to: Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e)CTD submissions.
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met, and overall quality standards are maintained.
- Adheres to established regulatory standards, including but not limited to ICH– E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on– time, and on– budget.
- Performs on– line clinical literature searches, as applicable.
- Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
- Understands budget specifications for assigned projects, working within the budgeted hours, and communicating changes to medical writing leadership.
- Performs other work– related duties as assigned. Minimal travel may be required (less than 25%).
- Develops good working relationships with internal and external colleagues.
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines strongly preferred.
- Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team– oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
We positively value all work or study experience abroad.
All positions require a high level of English (at least B2) – please send your detailed CV in English.
