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Title: Principal Medical Writer (Regulatory)

Location: Hybrid (3-4 days onsite) Lexington, MA

Duration: Direct Hire

Salary + Bonus

RESPONSIBILITIES:

Responsibilities (including, But Not Limited To)

Manages medical writing projects to prepare clinical/regulatory documentation (e.g., clinical study protocols, clinical study reports, investigator brochures, regulatory submission modules) in support of clinical development, clinical studies, and regulatory submissions, presenting clinical data objectively and clearly in a concise format consistent with industry guidelinesManages the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processesLeads the technical editing activities for assigned projects and reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standardsActively supports cross-functional project teams, representing Medical Writing and taking responsibility for timely and accurate Medical Writing deliverables, negotiating timelines as necessarySolves problems associated with Medical Writing scope of work, seeks advice from in-line management and others as needed, and exercises negotiation and communication skills with project team membersMay participate in orientation and coaching of junior team members or working in collaboration with Medical Writing contractorsParticipates in and leads within- and across‑department efforts to continuously improve Medical Writing processes and standardsProduces high-quality documents with minimal supervision to meet aggressive timelines, ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)Stays up to date on and understands regulatory guidance regarding content for various clinical/regulatory documents and can apply this knowledge

Qualifications

6+ years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections)Bachelor's, Masters, or PhD degree in science, medical, clinical, or English/Communications required.Ability to lead/manage multiple projects in a fast-paced environment handling multiple demands and experience with project management software (e.g., MS Project, Smartsheet)Strong working knowledge of Adobe PDF, MS WORD, EXCEL, and PowerPointExperience with automated document templates and style guidesKnowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating proceduresAbility to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the team KK_1400310_1733241066 To Apply for this Job Click Here