Senior Medical Writer

Synterex, Inc.; Princeton (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Synterex, Inc. is a global consortium of medical writing, submission publishing, and clinical science professionals. We seek an organized, motivated senior medical writer to partner with client teams across Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

Location is fully remote, with on-site meetings when requested. The role leads document execution, timelines, cross-functional coordination, and adherence

Qualifications

• 5+ years experience as a medical writer in the CRO/biotech/pharma field.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.
• Familiarity with lean authoring approaches and structured content management.
• Familiarity with ICH and US regulatory requirements; ex-US knowledge is desired.
• Expertise with Microsoft Word and related MS applications.
• Experience developing documents using document management systems and collaboration tools.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents.
• Ensure document development adheres to client processes, templates, and instructional documents.
• Serve as an expert on client document management system and related tools, templates, and procedures.
• 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.
• Follow-up with individual team members to resolve outstanding review feedback.
• Ensure consistency among client programs in messaging, formatting, and presentation of documents.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives (templates, style guides, reference management).

Skills

Verbal and written communication

Project management

Independent and collaborative work

Client-facing collaboration

Attention to detail

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Job description

Job Description

Synterex, Inc. is aglobalconsortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support.Synterexoffers remote or on-site services, with a focus on providing clear, concise,accurate, and fully compliant documentation, from early drug development through post-approval.

Synterexisseekingan organized, motivated, and collaborative individual for our medical writing team.Theseniormedical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols, 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 attend key (e.g., roundtable or kickoff) meetings on site with clients asrequested.

Essential Duties & Responsibilities

• Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)to ensuretimelycompletion ofdocuments
• Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient documentdevelopment
• Lead document message development in collaboration withclient
• Interpret data and create shell documents to supportauthoring
• Plan and lead kickoffmeetings
• Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient)
• Follow-up with individual team members asneeded to resolve outstanding reviewfeedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments
• Conduct literature searches asneeded
• Perform peer QC review asneeded

• 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
• Bachelor’s degreeor higherin a relevant field
• Oncology, InfectiousDisease, or Vaccineexperiencedesired
• Experiencedesiredin writingclinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents
• Flexibility towork across multiple therapeutic areas, if needed
• Experiencewriting documents according toestablished processes and documenttemplates
• Familiarity with lean authoring approachesand 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 isdesired
• Expertisewith Microsoft Word and other Microsoft applications
• Experiencedeveloping documentsusingdocument management systems, collaborative authoringtools, and reviewtools
• Comfortableadaptingto newtools andtechnologies, if needed
• Ability to work both independently and collaboratively in the face of competingpriorities
• Service-oriented and proactive approach to projectmanagement
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based onpreviousexperience
• Strong written and verbal communication skills

Synterexprovides 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,stateor local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence,compensationand training.

Synterexparticipates in the Department of Defense’sSkillBridgeprogram. For more information, please visit www.synterex.com/fellowships-internships.