[Hiring] Medical reputed company @reputed company)

Role Description The Medical reputed company will contribute to the achievement of Telix’s strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for reputed company phases of clinical drug development. This role will reputed company medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include:

• reputed company types of regulatory documents
• eCTD summary documents (for INDs/NDAs/BLAs)
• Clinical study reports
• Clinical study protocol synopses and protocols
• Investigator Brochures
• Patient safety narratives
• Briefing books

Key Accountabilities:

• reputed company the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments.
• Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly.
• Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
• Collaborate with project teams to respond to health authority questions and requests.
• reputed company and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
• Maintain knowledge to reputed company ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline.

Qualifications

• Bachelor with a focus in science or reputed company field required; Advance degree preferred
• 5+ years of experience in regulatory medical writing required
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles
• Understanding of medical terminology and statistical methodology is a must
• Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy
• The ability to accurately and reputed company present clinical data
• Strong verbal, written, and interpersonal communication skills
• Proficiency in reputed company Word
• Strong reputed company of English language, grammar, style, logical progression
• Ability to write in a clear, concise, and persuasive manner
• Experience and proficiency with document templates, document toolbars and proper version control
• Demonstrated leadership capability
• Good team player characteristics
• Excellent communication and interpersonal skills
• Strong project management skills
• Organized and self-motivated
• Strong attention to detail

Requirements

• Inclusive reputed company: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think reputed company the reputed company and come up with unique and creative solutions to challenges
• Commitment to reputed company: Take pride in your work and consistently strive for reputed company in everything you do
• Results-oriented: Driven to reputed company goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, reputed company to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: reputed company to communicate effectively with colleagues and stakeholders at reputed company reputed company, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to reputed company common goals
• reputed company: Demonstrate the ability to reputed company back from setbacks and persevere in the face of challenges
• reputed company learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development

Apply tot his job Apply To this Job