What are the responsibilities and job description for the Medical Writer position at Randstad Life Sciences US?
A world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes. Throughout, we’ve worked tirelessly to make a difference by pursuing bold science while respecting, educating, and connecting with patients. Through our expertise in genetics and molecular biology, we have been able to develop targeted therapies that address the root cause of the exact conditions we seek to treat.
We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the drug development expertise to unlock cures to many therapies.
KEY SKILLS;
CLINICAL REGULATORY DOCUMENTS
CLINICAL STUDY REPORTS
MEDICAL WRITING
CLINICAL REGULATORY SUBMISSIONS
Job Description :
Major Duties and Responsibilities :
May include but not limited to the following :
- Demonstrated ability to communicate and write English clearly, concisely, and effectively
- Well-organized : ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities / demands
- Independently motivated with good problem-solving ability
- Excellent interpersonal skills; a team player
- Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
- Strong project management skills
- Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments
- Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines
- Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus
- The technical / scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
- Working knowledge of drug / biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Ability to comply with company and / or industry style guides and templates
- Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint
Requirements : Education :
Experience :
