Synterex

Lead and coordinate the preparation of high-quality clinical regulatory documents and manage project timelines and stakeholder communication. | 5+ years medical writing experience in CRO/biotech/pharmaceuticals with knowledge of clinical study reports, protocols, regulatory requirements, and document management. | Synterex, Inc. is a global 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 senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical 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.Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.Essential Duties & ResponsibilitiesLead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents.Ensure document development adheres to any relevant client processes, templates, and instructional documents.Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development.Lead document message development in collaboration with client.Interpret data and create shell documents to support authoring.Plan and lead kickoff meetings.Facilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient).Follow-up with individual team members as needed to resolve outstanding review feedback.Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents.Conduct literature searches as needed.Perform peer QC review as needed.Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed.RequirementsExperience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field.Bachelor’s degree or higher in a relevant field.Oncology, Infectious Disease, or Vaccine experience desired.Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.Flexibility to work across multiple therapeutic areas, if needed.Experience writing documents according to established processes and document templates.Familiarity with lean authoring approaches and structured content management.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.Experience developing documents using document management systems, collaborative authoring tools, and review tools.Comfortable adapting to new tools and technologies, if needed.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.Comfortable providing suggestions based on previous experience.Strong written and verbal communication skills.For further information or to apply, please reach out to careers@synterex.com.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.Synterex participates in the Department of Defense’s SkillBridge program. For more information, please visit www.synterex.com/fellowships-internships. #J-18808-Ljbffr

Lead and manage the preparation of high-quality clinical and regulatory documents, coordinate cross-functional teams, and mentor junior writers. | 10+ years medical writing experience in CRO/biotech/pharma, advanced degree preferred, familiarity with regulatory requirements and document management systems. | Synterex, Inc. is a global 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 principal medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the 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.Location: Fully remote position, preferred ability to attend roundtable meetings on site with clients as requested.Essential Duties & ResponsibilitiesProvide strategic direction for medical writing projects as the lead writer, including development of submission-level key messages with cross-functional input and creation of project lexicons with harmonized terms.Serve as the main point of client contact for issues spanning multiple document types.Organize and proactively manage execution of content, timelines, and resources.Coordinate activities, provide review, and substantively edit cross-functional team/co-authored contributions.Mentor junior writers and develop soft skills needed to successfully navigate team dynamics, comment resolution, and other factors to promote a positive team authoring experience.Coordinate internal stakeholder input 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.Plan and lead kickoff meetings and roundtable meetings for each document draft; vet comments following team review to ensure efficient 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).RequirementsExperience (10+ years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalent.Advanced degree preferred.Oncology experience is a plus.Experience as a lead writer for key documents.Experience successfully managing major submissions.Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US/EMA regulatory requirements; working knowledge of other 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