Medical writer

• Demonstrate understanding for multiple products and disease states
• Interact with internal teams (Account, PM, creative, etc.) and clients on programs to meet strategic objectives.
• Work closely with the Associate Medical Director in managing multiple accounts from a scientific perspective including all scientific and strategic aspects of medical communication tactics, meetings, and programs
• Participate in strategic planning and project meetings with internal and client teams as needed
• Self-educate on innovation in the industry and begin to conceptualize programs for teams
• Develop depth of understanding for assigned products, related medical areas, and competitors on an ongoing basis
• Identify and communicate important updates and medical-regulatory milestones to the team and recommend new business opportunities
• Collaborate with the Editorial team to resolve grammatical or stylistic errors or concerns
• Take a proactive solutions-oriented approach into all assignments

Senior Medical Copywriter

• Facilitating the improvement in the overall quality and completeness of provider-based clinical documentation in the medical record
• Assisting treating providers to ensure documentation accurately reflects diagnostic-related group, severity of illness, risk of mortality, risk adjustment, and complexity of patient care rendered
• Conducting accurate and timely concurrent record reviews
• Ensuring data integrity of the clinical documentation database
• Educating customers through presentations and reports on documentation opportunities

RN Clinical Documentation Specialist

• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations
• Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity
• Collaborate with cross-functional teams to gather and synthesize information for document development
• Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards
• Mentor and train junior medical writers, fostering a culture of excellence and professional growth
• Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs
• Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

Principal Medical Writer

• Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs
• Leads in a team environment and matrix
• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
• Leading cross-functional (eg, with clinical team) document planning and review meetings
• Interacting with cross-functional colleagues on document content and champions MW processes and best practices
• Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision
• Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical)
• Coaching or mentoring more junior staff on document planning, processes, and content
• Provides peer review as needed.

Medical Writer III

• Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs.
• Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs.
• Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department.
• Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer).
• Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF).
• Contributes to the development of document templates and relevant SOPs.
• Represents the platform on committees and working groups within Clinical as requested.
• Provides mentoring support to less experienced colleagues and new Company staff members if needed.
• Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing.
• Is in charge of supervising subcontracted medical writing activities if needed. May contribute to the updates of templates, SOPs, and other guides for Medical Writing.

Senior Medical Writer – Vaccine

• Research, write, and revise high-quality, original editorial content
• Ensure scientific accuracy while editing and referencing
• Liaise with clients, authors and colleagues to progress projects effectively
• Attend congresses, symposia and advisory board meetings as required and liaising with speakers and clients
• Provide input on project specifications, costings and schedules, working with the internal account team to ensure projects are delivered to time and budget
• Provide good briefings to colleagues and freelancers
• Actively participate in account development meetings to grow repeat business
• Mentor new writers

Senior Medical Writer – Medical Communications

• writes original content for publications activities, and other materials for healthcare professional (HCP) and internal client audiences
• demonstrates a command of relevant therapeutic areas and expertise with assigned products
• analyzes, interprets, and applies clinical data to produce high-quality scientific communications
• follows all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices

Senior Medical Writer

• Deliver formal education to staff and providers
• Develop impactful learning modules
• Conduct audits to ensure accuracy and continuous improvement
• Assist with onboarding new hires
• Provide ongoing, continuing education and competency assessments
• Perform concurrent, retrospective, and secondary clinical chart reviews

Medical writer jobs in Pennsylvania

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