Job Description

Job Description

Job Description

Salary:

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-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management in planning and preparation of high-quality clinical and regulatory documents. The medical writer mayproduceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines.

Location:Fully remote,but must be able to attendkey (e.g.,roundtableor kickoff)meetings on site with clientsas requested.

Essential Duties & Responsibilities

• Manage execution of documents, including creating,maintaining, and communicatingtimelines
• Coordinatecross- functionalclientcontributors and stakeholdersas well asinternal resources (e.g.,quality control [QC], publishing)
• Serve as an expert on clientdocument management system and related tools, templates,and procedures to ensure efficient documentproduction
• Leaddocument message developmentin collaboration with client
• Plan and leadkickoffmeetingsandroundtable meetings for eachdocumentdraft; 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 peerQC review as needed
• Contribute to medical writing operationalinitiatives(e.g., templates, style guides, reference management)

Requirements

• Experience (5+ years) as a medical writerin the CRO/biotech/pharmaceutical field, or equivalent
• Bachelors degree in a relevant field
• Oncology experience
• Familiarity with the requirements for preparation of key clinical and regulatory documents, includingICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
• Expertise withMicrosoft Wordand other Microsoftapplications
• Familiarity withdocument management systems
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellentconflict management and negotiation skills
• Strong written and verbal communication skills

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.

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.

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