Medical Writer Consultant
Apply NowLocation:
New Providence, NJ, US
Company:
ADC Therapeutics is a commercial leader specializing in antibody-drug conjugates, focusing on innovative cancer therapies.
Summary:
The Medical Writer Consultant will coordinate, author, and edit important documents for clinical trials and regulatory submissions. Applicants must have at least a BS/MS or science degree and over 10 years of relevant oncology clinical research experience.
Requirements:
Hard Skills: Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems., Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting., Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates., Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports)., Ability to interpret and summarize complex tabular and graphical data presentations., Strong organization, documentation and communication skills with an ability to multitask., Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
Credentials: BS, MS, RN, NP, MSN, PharmD, PhD, MD
Experience: 10+ years of oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical industry., Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA)., Experience writing, at a minimum, protocols (Phase 1-3, in oncology TA), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.
Job Description:
Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and has also received European Commission approval. ZYNLONTA® is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We consist of nearly 300 dedicated employees, all focused-on patient care and driven by purpose, who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
in the lives of patients learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on LinkedIn.
This is a 6-month contract position with the potential for extension, contingent upon business needs and individual performance.
What You’ll Do
- Coordinate, author and edit documents used to support clinical trial conduct and reporting, regulatory interactions and submissions, including but not limited to:
- Develops directly or supports a variety of documents that include, but not limited to:
- Clinical study protocols and clinical protocol amendments
- Clinical study reports
- Patient narratives
- Investigator brochures
- Clinical development plans
- IND submissions and annual reports, DSUR, etc.
- Integrated summary reports
- NDA, BLA, MAA, (e)CTD submissions
- Health Authority responses
- Regulatory meetings background briefing books
- BLA module 2 summary documents (efficacy summary, safety summary etc.)
- Scientific publications
- Prepare clinical trial disclosures and registration datasets for ClinicalTrials.gov, EudraCT, and CTRI registries and gain internal/registry approvals; and populate data within websites for public release.
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Maintain document prototypes and shells, proactively support developing and reviewing standard operating processes, templates and any applicable style guide.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Manage directly or support management of External Service Providers for medical writing related tasks.
- Review and edit documents as required.
- Work effectively and lead in cross-functional working groups.
