Manager, Medical Writing Quality Control
Conducts Quality Control of numerical data and formatting in R&D documents including regulatory submissions. Performs Quality Control to support other types of documentation for external presentation, including Data Safety Committees, Investigator meetings etc. Supports, authorizes, and manages the review and approval of clinical and regulatory documents for R&D.
Essential Job Functions:
- Performs detailed quality control review checks of R&D documents including, but not limited to, clinical study reports, plan outlines, protocols, documents for regulatory submissions (e.g., meeting packages, investigational new drug [INDs] applications, sections of marketing applications [NDA/MAA/CTD]), investigator brochures, posters, manuscripts, or other clinical and regulatory documents, such as agency responses.
- Manages and ensures adherence to the Avanir approved template and style guide in documents for regulatory submission.
- Performs QC to supports other types of documentation for external presentation, including Data Safety Committees, Investigator meetings, nonclinical and CMC documents etc.
- Copyedits, proofreads, or substantively content-edits documents, including grammar, spelling, style, and layout.
- Ensures that document content is consistent with internal and ICH guidelines.
- Works with Medical Writing Lead and project manager to develop a thorough understanding of project timelines
- Works across departments to help set priorities for document preparation and manage internal authors as needed to deliver documents in the required timelines.
- Manages external contract/CRO QC resources as needed.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- BS/MS/PhD/PharmD with a minimum 8 years of experience working on medical writing or medical document quality control in the biotech/pharmaceutical industry
- 3-5 years of experience in electronic document management systems and submissions
- Understanding of submission components, timing, and assembly.
- Knowledge of publishing software and tools used throughout the industry, including MS Office, Adobe Acrobat, and related programs.
- Experience in managing document templates and ensuring adherence to writing style guides
- Demonstrated advanced writing skills, with strong command of English language and grammar Strong oral and written communication skills
- Efficient, organized, and able to handle short timelines in a fast-paced environment
- Ability to work both independently and collaboratively
- Ability to identify issues and propose solutions
- Strong interpersonal, communication, and organizational skills; ability to work cross-functionally and collaborate with stakeholders across the organization
- Experience with clinical trial protocols, investigator's brochures, CSRs, safety narratives, other safety reports, or CTD clinical summaries
- Experience in multiple therapeutic areas, with prior experience in CNS preferred.
- Knowledge of regulatory guidelines related to clinical development and regulatory marketing applications
- Demonstrated project management skills and on time delivery of documents
- Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, Visio, etc.)
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.