Responsibilities
- Write / critically review study reports, coordinate writing efforts, and harmonize document writing processes.
- Coordinate the process of data review and visualization with therapeutic areas and cross-functional teams.
- Develop strong working relationships with key internal stakeholders.
- Identify internal and / or external business challenges and recommend best practices to improve products, processes, or services.
- Leverage understanding of company structure to bring together different functional areas to establish, harmonize, and / or synergize processes.
- Lead sub-streams or participate in large cross-functional project teams to solve complex problems by using analytical thinking, tools, and judgment to identify innovative solutions for Spark or an identified area within the company.
- Develop new approaches to complex problems and influencing others to change their point of view and leading others to solve the problem.
- Lead relevant team meetings.
- Lead document planning sessions including template development, data analysis / visualization / interpretation, document flow, key messaging, etc. Contribute scientifically at the project and / or study team level.
- Critically review scientific writing deliverables across the Research & Technology organization for clarity, accuracy, consistency, and alignment with company position; resolve issues, errors, or inconsistencies with pertinent team members to ensure optimal communication between teams.
- Serves as a mentor for colleagues with less experience.
- Other assignments as required.
Education and Experience Requirements
Graduate degree (PhD preferred) in a relevant scientific discipline (e.g., cell biology, molecular biology, genetics, etc.).Minimum of 3-5 years of experience in scientific / medical writing; experience in an industry setting (biotechnology, pharmaceutical, healthcare communications agency, etc.) is preferred.Ability to interpret internal or external business challenges and recommend best practices to improve products, processes, or services.Ability to analyze and interpret complex data from a broad range of scientific disciplines; understanding of statistic fundamentals.Experience in gene delivery systems (especially, but not limited to, AAV-based gene therapy) and / or key therapeutic areas such as metabolic, ocular, and / or CNS disorders is a plus.Understanding of mechanisms underlying innate and adaptive immune responses upon in vivo gene therapy is preferred.Knowledge of AAV production, characterization, and / or analytical method development is preferred.Key Skills, Abilities, and Competencies
Knowledge of principles and processes of drug development and regulatory documentation.Experience writing and managing the production of nonclinical documents; serves as a best practices / quality resource.Technical expertise in typical office applications (Microsoft Office, Adobe Acrobat), GraphPad Prism, reference management software (e.g., EndNote), and shared document systems (e.g., SharePoint).Manage timelines and quality of work using strong organizational, communication, and interpersonal skills; ability to multitask.Communicate difficult concepts and negotiate with others to adopt a different point of view.Lead functional teams or (parts of) cross-functional projects with moderate resource requirements, risk, and / or complexity; ability to facilitate discussions and decision-making with cross-functional team members.Proactive, flexible, and continuous growth mindset.Considered an expert in the field within the organization.Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify innovative solutions.The incumbent will collaborate with all therapeutic area leads, and all relevant departments involved in document filings and submission.Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $92,200 to $138,200.
Spark Therapeutics does not accept unsolicited resumes / candidate profiles from any source other than directly from candidates. Any unsolicited resume / candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
Total Rewards : Compensation & Benefits
Spark® offers a competitive, flexible, and comprehensive Total Rewards package that can be customized to fit your personal needs. Our program is designed to support the holistic wellbeing of employees and their families by providing health coverage, retirement savings plan, and a range of voluntary benefits for financial protection and peace of mind.
For all employees, our core total rewards package includes industry competitive salaries; bonus eligibility; and long-term incentive eligibility, including both new hire and annual grant opportunities.
We do everything we can to make working at Spark rewarding for you.
Your Health & Wellbeing
Medical and Prescription DrugsDental and VisionHealth AdvocateHealth Savings Accounts (HSA)Flexible Spending Accounts (FSA)Your Financial Protection
401(k) Retirement Savings PlanFinancial PlanningLife and Disability InsuranceIdentity Theft ProtectionDiscounted Pet, Auto, and Home InsuranceYour Work / Life Balance
Time Away from Work Paid Time Off (PTO) − Use for vacation, illness or personal timeHolidays − Observance of up to 12 designated holidays, two floating holidays, plus a winter shutdownVolunteer Days − Up to two volunteer days per yearSpark Unplugged Half Days − Designated alternate half day Fridays year-roundPaid Parental Leave − Fully paid pregnancy leave up to 16 weeks total for birth mothers and up to eight weeks for parentsMental Health Support Program which includes coaching and therapyEmployee Assistance Program (EAP)Tuition Reimbursement ProgramMobile Phone AllowanceCompany Paid Commuter ProgramAdoption Assistance ProgramCare@Work MembershipLifeMart Discount Programthat are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers. The machine-readable files are formatted to allow researchers, regulators, and application developers to more easily access and analyze data.