Senior Medical Writer
Senior Medical Writer
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Salary Not Disclosed
1 Vacancy
Job Description
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 senior 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 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 & Responsibilities
- Lead the of documents including project management tasks such as creating maintaining and communicating timelines
- Coordinate crossfunctional 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
- Followup 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
Requirements
- Experience 5 years) as a medical writer in the CRO/biotech/pharmaceutical field
- Bachelors 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 exUS 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
- Serviceoriented 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 .
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 Defenses SkillBridge program. For more information please visit www.synterex/fellowshipsinternships.
Required Experience:
Senior IC
Employment Type
Full-Time
