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Remote Medical Writer (Project Management)

Cambridge, MA 02139

Posted: 06/05/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 608243 Is job remote?: Yes Country: United States

Job Description


Responsible for:
  • Supervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy.
  • Collaborate with cross functional teams providing timelines and overall medical writing document management
  • Support and guide all clinical regulatory documents to be included in eCTD submissions and other global health authority (HA) submission types, including all original applications, information requests, amendments, responses, and all other clinical submission types.

 

Responsibilities:
  • Provide MW project management, document timeline knowledge and effective communication across the portfolio to ensure accurate and timely delivery of clinical and regulatory documents to global health authorities.
  • Collaborate cross-functionally with department heads, document leads and subject matter experts (SMEs) across the business (ex., Clinical Research, Medical Affairs, Clinical Operations, Pharmacovigilance, Clinical Pharmacology, etc.) to prepare a compelling, consistent, high-quality, clinical regulatory messaged documents grounded in science and fluent with global regulations.
  • Understand clinical data, information, references, and other sources to lead and align with document authors and program teams to prepare and present data and document messaging consistent with regulatory requirements, guidelines, and program strategy.
  • Coordinate document roundtables, reviews, approvals, quality control (QC) and other document content issues and overall questions during the authoring process, including technical troubleshooting as needed.
  • Communicate with leadership, stakeholders and SMEs regarding document timelines, milestone progress and resources (as needed) throughout the duration of the document lifecycle/submission/program.

Qualifications:
  • Bachelors degree required
  • 3+ years of regulatory document project management oversight/experience. Proven experience in medical/clinical/regulatory writing in the pharmaceutical / biotechnology / healthcare industry a plus.
  • Solid understanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documents.
  • Knowledge and expertise with Common Technical Document structure and content templates, electronic document management systems and information technology. Excellent working knowledge of software programs in Windows environment.

Capabilities:
  • Superb project and information management skills
  • Overall communication which includes excellent written, verbal, and interpersonal (non-verbal communication).
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