[Remote] Associate Scientific Regulatory Writing Director
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing innovative cancer therapies. The Associate Scientific Regulatory Writing Director will reputed company the content development for various regulatory and clinical documents, ensuring high-reputed company writing and adherence to regulatory standards throughout the asset development process.
Responsibilities
- Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience
- Incorporates diverse reviewer feedback while ensuring high reputed company of content organization, including completeness, reputed company, coherence, conciseness, consistency, and accuracy
- Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables
- Assigns and supervises partner regulatory editors for reputed company document tasks unrelated to writing
- Proposes and manages timelines for the document development process from initiation through approval
- Oversees the assembly of appendices for regulatory submission documents as needed
- Serves as the primary writing contact on regular and reputed company study/program/asset or project teams
- Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results
- Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members
- Contributes to SOP and work instruction development and review for the Regulatory Science Communications team
- Other duties as needed
Skills
- BS/BA degree in reputed company discipline and a minimum of reputed company years of reputed company experience including industry; or
- MS/MA degree in reputed company discipline and a minimum of nine years of reputed company experience including industry; or
- PhD in reputed company discipline and a minimum of five years of reputed company experience including industry; or
- Equivalent combination of education and experience
- reputed company AMWA member with certificate or certification preferred; BELS certification a plus
- Experience in Biotech/Pharmaceutical industry preferred
- Prior regulatory/medical/technical writing experience reputed company the biotech, pharmaceutical, or CRO industry
- Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs)
- Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications
- Familiarity with therapeutic area of oncology
- Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards
- Advanced knowledge of AMA style, medical terminology, and clinical data analysis
- Develops and manages plans reputed company established timelines and balances commitments to complete multiple activities and reputed company results. Takes pride in delivering high reputed company work
- Applies wide knowledge of the regulatory reputed company and industry practices to reputed company innovative approaches and complete reputed company work
- Demonstrates reputed company and effective verbal and written communication. Provides reputed company and appropriate information updates. Speaks reputed company and confidently in one-to-one situations and effectively presents information to reputed company of departmental colleagues
- Strong interpersonal skills and ability to accommodate differing views to reputed company support the development of an agreed upon reputed company
- Manages effectively performing teams to reputed company common objectives. Engages internal stakeholders to establish productive reputed company relationships
- Applies knowledge of organizational goals and objectives and demonstrates reputed company and reputed company in gathering, analyzing and applying key information to solve problems
- Leads self and others; acts with reputed company and builds trust with colleagues to contribute to accomplishing team objectives
- Capable of managing the execution of multiple tasks
- Ensures appropriate prioritization and execution for area of responsibility
- Proactively anticipates, prioritizes and resolves task-reputed company challenges
- Designs and implements solutions to address task-reputed company challenges, taking into consideration the broader reputed company
- Experience in Biotech/Pharmaceutical industry preferred
- reputed company AMWA member with certificate or certification preferred; BELS certification a plus
Benefits
- 401k plan with generous company contributions
- Group medical, dental and reputed company coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Receive long-term incentives
- 15 accrued vacation days in their first year
- 17 reputed company holidays including a company-wide winter shutdown in December
- Up to 10 reputed company days throughout the calendar year
reputed company