- This position is accountable for the timely delivery of high quality, regulatory-compliant clinical document deliverables for our company.
- This position will lead the medical writing activities across a disease area or set of clinical programs.
- The scope of this position includes the management and oversight of clinical study protocols, Investigator’s Brochures, clinical study reports, and collaborate on smaller scope regulatory submission documents, risk management plans, briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents with minimal supervision
- Develop and implement clinical document strategy for clinical documents, including clinical study protocols, clinical study reports, Investigator’s Brochures and updates, smaller scope regulatory submission documents (includes Module 2 summaries), risk management plans, contributions to briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents, working cross-functionally and with minimal supervision.
- Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
- Actively supports clinical project team(s), representing Medical Writing and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
- Participates with other medical writing team members to formulate writing strategies and standards to be implemented and takes responsibility for execution.
- Develops effective collaborations with other functional lines in our company, and externally with regulatory, industry, professional, and academic organizations
- Ensures consistent support and implementation of medical writing standards
- Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards.
- Ensures that all activities are conducted in compliance with relevant regulatory requirements.
- Partners with Scientific Communications to support clinical trial results, publication activities, and scientific presentation and promotional material for assigned projects
- Maintains adherence to uniform processes and stands in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues.
- At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
- Experience with global trials and regulatory submissions preferred
- Experience with partnering and managing CRO relationships a plus
- Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of medical writing processes and systems across multiple projects
- Experience desired in medical writing for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing medical writing for ultra-rare disease studies
- BS degree in life sciences or equivalent required; advanced degree in a relevant scientific/clinical/regulatory field preferred
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas