The Medical Writer will coordinate and lead the medical writing aspects of Disc Medicine’s regulatory and clinical documents for two clinical stage programs. The Medical Writer collaborates with members of cross-functional teams to prepare high-quality regulatory documents, clinical protocols, investigator brochures, synopses, and related documents within agreed-upon timelines.
To perform this job successfully, an individual must be able to:
- Prepare, edit, and finalize regulatory documents, protocols, investigator brochures, synopses, and related documents, including scientific publications.
- Participate in scientific communication planning, including development of strategic medical communication plans.
- Work closely with the study team to ensure that results and messages in regulatory and clinical documents accurately reflect the data, messaging, and themes from other information sources.
- Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes.
- Work closely with the study team to reach consensus on timelines for deliverables.
- Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokineticists 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 clarified and appropriately addressed.
- Ensure SOP and regulatory compliance related to medical writing.
- Understand align with the program team in delivery of documents to meet project-related goals and to meet external results disclosure obligations.
- Manage all aspects of outsourced or internal CSR production and ensure project delivery.
- 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.
- Ensure documents are appropriately stored in the document management system.
- Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables.
- Suggest or identify changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity.
The ideal candidate will offer:
- At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
- Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry.
- 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.
- 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 to deliver on timelines.
- Adapt to change as needed; possess excellent project management skills; attentive to details.
- Ability to communicate with teams to set realistic timeline expectations; 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.
- Read, write and speak fluent English; excellent verbal and written communication skills.
ABOUT DISC MEDICINE:
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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