Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in planning and preparation of high-quality clinical and regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines. Initial contract length: 3 to 6 months, with potential for extension. Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested. Essential Duties & Responsibilities Manage execution of documents, including creating, maintaining, and communicating timelines Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document production Lead document message development in collaboration with client Plan and lead kickoff meetings and roundtable meetings for each document draft; curate review comments to ensure efficient roundtable meetings; plan and lead roundtable meetings Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents Perform peer QC review as needed Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management) Requirements Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalent Bachelor’s degree in a relevant field Oncology experience Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired Expertise with Microsoft Word and other Microsoft applications Familiarity with document management systems Ability to work both independently and collaboratively in the face of competing priorities Service-oriented and proactive approach to project management Excellent conflict management and negotiation skills Strong written and verbal communication skills Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. For further information or to apply, please reach out to careers@synterex.com. If anyone tries to contact you that does not come from a synterex.com email address or our HR system BambooHR, please delete and disregard the message as phishing scams are at an all-time high. #J-18808-Ljbffr Synterex
...Job Title: Airline Cargo Truck Dispatcher Location: Hawthorne, CA (Near LAX) Work Type: On-Site, Full-Time (Part-Time Available) Compensation: $26.00/hour (DOE - Depending on Experience) Join Our Team as an Airline Cargo Truck Dispatcher Are you a skilled...
...passionate about making a positive impact on the lives of young girls and helping them develop... ...world. Position Summary The Camp Property Manager is responsible for the daily operations,... ...Requirements Ability to live on-site at the resident camp year-around....
...a learning culture. We offer programs to assist with tuition reimbursement, professional designations... ...Insurance Company, is seeking an attorney with 3+ years of civil litigation and... ...required to be eligible to lawfully work in the U.S. immediately; employer will not sponsor...
Subscribe to FlexJobs today and gain access to 25,000 hand-screened remote, work from home, & flexible schedule job listings. FlexJobs makes it easier, faster, and safer to find a job that better fits your life with professional job opportunities from entry-level to executive...
...Job Description Job Description Textile Machine Operators | $16.50 Hour | 2nd & 3rd Shift What Matters Most Competitive Pay starting at $16.50 and up DOE Schedule: Monday Friday 2nd and 3rd shift Location: Kings Mountain, NC Temp to Hire Opportunities...