Senior Medical Writer

Job Description

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

Synterexisseekingan organized motivated and collaborative individual for our medical writing writer will partner cross-functionallywith client teams inClinical Development Clinical OperationsBiostatisticsRegulatory and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols publications study reports investigator brochuresnarrativesand module documents according to clientand agency guidelinesto 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 ascreatingmaintaining 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
• Bachelors 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

For further information or to apply please reach out

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 federalstateor local laws.

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

Synterexparticipates in the Department of DefensesSkillBridgeprogram. For more information please visit Experience:

Senior IC