Job Summary
This position is accountable for the timely preparation of high-quality, regulatory-compliant clinical document deliverables. The successful candidate will support medical writing activities for one or more clinical programs with moderate supervision.
Key Responsibilities
* Support clinical project teams by authoring and managing the development and completion of high-quality clinical regulatory documents, including clinical study protocols, clinical study reports, Investigator's Brochures, and clinical Common Technical Document components.
* E nsure strategic organization, clarity, accuracy, format, and consistency of scientific content.
* Represent medical writing cross-functionally and with external vendors, negotiating timelines as necessary.
* Participate with other medical writing team members to develop and implement processes and standards, and take responsibility for execution in cross-functional teams.
* Maintain adherence to internal guidelines, styles, processes, standard operating procedures, and regulatory requirements in partnership with colleagues from statistical, clinical, regulatory, quality, and patient safety functions.
* Develop effective collaborations with other functional lines within Alexion, and stay up-to-date on regulatory, industry, and medical writing knowledge and best practices.
Requirements
* 3-5 years of regulatory writing experience; may consider fewer years of writing experience combined with other relevant experience.
* Demonstrated capability to understand and summarize complex clinical data, and write and manage clinical study documents.
* Knowledge of global regulatory requirements and ICH/GCP guidelines.
* Excellent oral, written, and presentation skills; advanced user of MS Office suite.
* Results- and compliance-driven; sets standard of excellence for self and others.
* The duties of this role are generally conducted in an office environment.
Preferrred Qualifications
* MS or PhD degree in a relevant scientific/clinical/regulatory field.
* Ability to establish excellent internal and external relationships, including alliance partners and vendors.
* Team player who thrives in a team-based environment.
* Well-developed sense of ethics, responsibility, and respect for others.
* Agile learner with ability to work both collaboratively and independently.
* High level of flexibility and ability to innovate and adapt.