Principal Medical Writer

Job Description

Job Description

Salary :

Principal Medical Writer

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 & Responsibilities

• Provide 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 (eg, templates, style guides, reference management)

Requirements

• Experience (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
• Experiencing 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 system s
• 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 [email protected]. 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.