Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
Primary duties will encompass management of both clinical and regulatory writing resource and activities. The Director, Head of Medical Writing leads the writing/manages the resources assigned to clinical, nonclinical, and regulatory documents according to applicable regulations. Clinical documents will include protocols, Investigator's Brochures, consent forms, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of IND's, NDA's, and other regulatory submission documents. In addition, this role may assist in authorship of abstracts, posters and manuscripts, and patient education materials.
The Head of Medical Writing represents the Medical Writing function at key cross functional teams (e.g. Global Development Team, filing teams, Global Regulatory Team meetings) and works closely with the Regulatory Science staff as a key member of the Regulatory Science department.
* As assigned. works with clinical team to prepare protocols, study reports and investigator brochures under strict timelines
* Works with the Regulatory Science department to prepare other regulatory documents such as regulatory briefing packages, CTD summaries and overviews, and any other regulatory document required for submission
* Provides senior oversight of documents quality and consistency. Ensures efficient formatting of documents; ensures a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier and briefing package / book
* Contributes to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
* Helps position and maintain Medical Writing as a strategic partner to the other development functions throughout the lifecycle of a project
* Plans and manages Medical Writing resource (FTE and/or contractor resource), which includes assignment of the appropriate level of medical writing support to the right team at the right time, in close collaboration with other development functions
* Ensures continuous awareness of the Medical Writing activities, plans, scope of work and ways of working across the organization
* Excellent writing skills for professional and patient education materials and able to write medical documents independently
* Perform medical literature research and interpret medical literature independently
* Knowledge of medicine and disease states
* Strong familiarity with medical terminology
* Prioritize multiple tasks and transition between activities depending upon corporate needs
* Proficiency in Microsoft Word, Outlook, Microsoft Excel
* Excellent organizational skills and attention to detail
* Perform all essential job functions under the constraint of tight timelines
* Flexibility in meeting the changing demands of each project
* Demonstrated ability to communicate and write English clearly, concisely, and effectively
* Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
* Working knowledge of drug / biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
* Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents and annual reports is a plus
* Recent and significant experience in writing of regulatory documents such as Clinical Study Reports, Protocols, Summaries, Overviews
* Accurate and detail-oriented
* Aptitude for compilation, analysis, and presentation of data
* Independently motivated with good problem-solving ability
* Ability to work with multiple contributors to produce a final unified document
* Enjoys a cohesive, motivated team-oriented work environment
* PhD, Master of Science Degree in a life science field. NP qualification, PharmD, RPh, or MD/DO preferred and a minimum of 10 years in the pharmaceutical industry and 10 years of experience as a medical writer, or in a management position in a pharmaceutical industry environment is required
Next Steps -- Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.