Principal Medical Writer
Principal Medical Writer
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Job Description
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 onsite services with a focus on providing clear concise accurate and fully compliant documentation from early drug development through postapproval.
Synterex is seeking an organized motivated and collaborative individual for our medical writing team. The principal medical writer will partner crossfunctionally with client teams in Clinical Development Clinical Operations Biostatistics Regulatory and Program Management in leading the planning and preparation of highquality 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 submissionlevel key messages with crossfunctional 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 of content timelines and resources
- Coordinate activities provide review and substantively edit crossfunctional team/coauthored 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 exUS 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
- Serviceoriented 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 . If anyone tries to contact you that does not come from a synterex email address or our HR system BambooHR please delete and disregard the message as phishing scams are at an alltime high.
Required Experience:
Senior IC
Employment Type
Full-Time
