Senior Medical Writer (Contract) Job at Synterex in Boston

Join to apply for the Senior Medical Writer (Contract) role at Synterex

Join to apply for the Senior Medical Writer (Contract) role at Synterex

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-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in 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.

Initial contract length : 3 to 6 months, with potential for extension.

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

Manage execution of documents, including creating, maintaining, and communicating timelines

Coordinate cross-functional client contributors and stakeholders 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

Lead document message development in collaboration with client

Plan and lead kickoff meetings and roundtable meetings for each document draft; 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 peer QC review as needed

Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management)

Requirements

Experience (5+ years) as a medical writer in the CRO / biotech / pharmaceutical field, or equivalent

Bachelor’s degree in a relevant field

Oncology experience

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 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

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 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.

Seniority level Seniority level Mid-Senior level

Employment type Employment type Contract

Job function Job function Marketing, Public Relations, and Writing / Editing

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