Location: Portsmouth, NH, US, 03801 Philadelphia, PA, US, 19104 Richmond, VA, US, 23173 Princeton, NJ, US, 08540 Baltimore, MD, US, 21287 Hartford, CT, US, 06101 Houston, TX, US, 77014 Stamford, CT, US, 06831 Dallas, TX, US, 75166 Charlotte, NC, US, 28105 Parsippany, NJ, US, 07005 Atlanta, GA, US, 30301 Boston, MA, US, 02114 Roanoke, VA, US, 24001 Charlotte, NC, US, 28105 Miami, FL, US, 33138 Wayne, PA, US, 19087 Chicago, IL, US, 60612 Orlando, FL, US, 32789 Pittsburg, PA, US, 15106

Description:

The Medical Writer is part of Global Clinical Development supporting conduct of clinical trial programs comprised of several pilot and pivotal trials in thoracic (e.g. lung), CNS (e.g. GBM), GYN (e.g. ovarian), and GI (e.g. pancreatic and hepatocellular) cancers.

The ideal candidate is someone who can convey scientific data and clinical research results in a clear, concise manner working in a multi-disciplinary with regulatory, clinical operations and other functions as necessary to support high quality core clinical document production including annual safety reports. In addition to producing content for clinical documents and safety reports, the employee would also create content for conferences or presentations on behalf of Clinical Development study teams. This role will allow the employee to support the novel technology of TTfields that has potential to shift the treatment paradigm as one of the few therapeutic device modalites in oncology.

This is a full-time, exempt, field-based role reporting to the Senior Manager, Clinical Research Scientist.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Collaborate with members of cross-functional teams to prepare, edit, and finalize high-quality core clinical documents including but not limited protocols, investigator brochures, synopses, regulatory documents, clinical safety reports, and related clinical documents within agreed-upon timelines.
• Collaborate with Clinical Development leadership and cross functionally to prepare, edit and finalize standard operating procedures and standardized templates for the Clinical Development Department
• Participate in scientific communication planning if relevant in coordination with the publication team that is part of medical affairs.
• Partner 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 narrative planning for relevant documents
• Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• When appropriate and relevant, collaborate with medical directors, clinical research scientists and biostatisticians to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manage the document review process ensuring conflicting and/or ambiguous comments are appropriately addressed while keeping appropriate version control
• Ensure that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Suggest or identify changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
• Partner with the appropriate functions to ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements

QUALIFICATIONS/KNOWLEDGE:

• At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
• Bachelor’s degree +4 years, Master’s Degree +2 years, Doctoral Degree +1 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology or in devices, preferably both.
• Familiarity with AMA style
• Ability to meet deadlines
• Organizational skills
• Medical/scientific and clinical research knowledge (oncology experience a plus)
• Very good presentation skills
• Advanced communication and interpersonal skills (both written and verbal)
• Strong writing skills, including grammar and language
• Able to work independently, exercise sound judgment, and escalate issues when necessary
• Able to work efficiently and collaboratively under pressure
• Able to communicate complex medical/clinical information in a succinct way
• Experience in interacting with cross functional study team members
• 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
• Proficiency in the use of Microsoft Word and other reference tools

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

Equal Opportunity Employer, including disability/veterans.

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