Clinical/Regulatory Writer, USA - L

CROMSOURCE - USA - Description: Job Title: Clinical/Regulatory Writer Location: United States, PST Time zone Contract: Full-time Remote, Permanent TalentSource Life Sciences is searching for an experienced Clinical/Regulatory Writer in the United States. The successful candidate will be working on studies dedicated to one client, one of the market leaders in ophthalmology solutions and studies. As this is a client-facing role, we are looking for confident candidates with a strong sense of responsibility and the ability to work independently, whilst establishing a high-trust environment with the client counter-parts. TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Whilst you are integrated into a sponsor-led team, you have the continuous support from your TalentSource line manager. Position Summary The Clinical/Regulatory Writer will report jointly to the Clinical Affairs Manager. This position involves the preparation of all regulatory documents for IND and NDA submission to the FDA; Summarizing data from preclinical and/or clinical studies; Coordinating the efforts of various functional teams to produce clear, high-quality and scientifically accurate documents. Your Responsibilities Prepare clinical regulatory documents including but not limited to: Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Study Protocols, clinical summaries in the Common Technical Document (CTD) format, Investigational Medicinal Product Dossier (IMPDs), Investigational New Drugs (INDs), New Drug Applications (NDAs) and other scientific publications; Prepare major regulatory submissions such as IND or NDA submission to the FDA; Write shell reports and summarize data from preclinical and/or clinical studies; Coordinate the efforts of various functional teams to produce clear, high-quality and scientifically accurate documents; Review all regulatory and clinical documents composed by external parties; Collaborate with Clinical Affairs Manager on high-priority projects that require synthesizing scientific studies into informative content. Your Qualifications Preferably a PhD in life sciences, chemistry, medicine or demonstrated experience working in a similar role in the bio-pharma industry is required; Minimum 3-5 years of clinical and regulatory writing experience within the pharma-/biotech industry; Extensive experience writing CSRs (ophthalmology is strongly preferred); Thorough understanding of the FDA processes and international regulations; Exceptional verbal and written communication skills, including the ability to use clear language to explain complex ideas required; Attention to detail is a must; Strong analytical/quantitative skills; Proven ability to work independently under deadlines and to work in a rapidly changing environment; Highly motivated, passionate self-starter who is proactive and confident in identifying problems and solutions. If you have the experience needed for this position, please apply directly to our website https://ift.tt/3ijzfnw . If you would like to discuss the role before applying through the website, please contact julie.casteleijn@cromsource.com for more information. Why TalentSource Life Sciences/CROMSOURCE: TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously. CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom. Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions. The success of these core values are evidenced by our below industry average turnover rates. By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor. Keywords: Clinical Writer, Regulatory Writer, Pre-IND, Ophthalmology, FDA Submissions Skills: Ophthalmology, Document Specialist, Medical Writer, Regulatory Documentation Scientist, IND, Regulatory, Regulatory submissions Location: United States Share: LinkedIn Facebook Twitter Email... - Permanent - Full-time

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