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Senior Medical Writer

CEDENT

Rockville, MD

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JOB DETAILS
SKILLS
Biostatistics, Biotech and Pharmaceutical, Brochures, Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Cross-Functional, Disease, Document Management, Documentation Plan, Documentation Review, Drug Development, English Language, FDA Requirements, GCP (Good Clinical Practices), ICH Regulations, Interpersonal Skills, Maintain Compliance, Management Strategy, Medical Protocols, Medical Writing, Multitasking, Oncology, Outsourcing, Pharmacokinetics, Presentation/Verbal Skills, Process Improvement, Project/Program Management, Publications, Quality Control, Quality Management, Regulations, Regulatory Submissions, Standard Operating Procedures (SOP), Standards Development, Statistics, Strategic Planning, Team Player, Writing Skills
LOCATION
Rockville, MD
POSTED
30+ days ago
The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

Essential Duties and Responsibilities:
  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Manages the document review process ensuring conflicting comments are appropriately addressed
  • Completes documents according to agreed-upon timelines and follow-up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance and reach consensus on timelines for deliverables
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Manages all aspects of outsourced or internal CSR production and ensures project delivery
  • Ensures that medical writing deliverables conform to the International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity
  • Aligning with department management to set strategy for meeting department goals
Qualifications:
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
  • Read, write and speak fluent English, excellent verbal and written communication skills
  • Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses.
  • Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines.
  • Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional teams.
  • Initiative and ability to handle a variety of projects simultaneously.
  • Excellent interpersonal and communication skills.
  • Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT.
Education/Experience:
  • (BA/BS) +8 years, (MS) +5 years, (Ph.D. or PharmD) Doctoral Degree+2 years of relevant corporate medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas;
  • 3 -8 years of regulatory writing and submission experience
  • An understanding of the drug development process
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Experience in interacting with cross-functional study team members

About the Company

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