Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking for a motivated candidate who will be responsible for ensuring the coordination and management of Chemistry, Manufacturing, and Controls (CMC) regulatory documents related to all pre- and post-marketing activities in all regulatory jurisdictions. Timely and efficient submission and approval of documents will be key to success for this role as CMC Technical Writer – Content, Strategy, and Development. The incumbent will collaborate with cross-functional department colleagues working within Rocket Pharma and other partners to ensure the successful execution of Rocket Pharma’s company business strategies and company objectives.
- Leads development, authoring, analyzing, and interpretation of CMC related technical data (from SOPs, Batch Records, Reports, etc.) to author INDs and IMPD sections, module 2 summaries (QOS), briefing documents, and other documents needed to support regulatory interactions and filings for CMC.
- Performs quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
- Reviews and aids in responding to requests for information from regulatory agencies, as required.
- Assists in the development of standard operating procedures, work instructions/guidelines, templates, style and content guides, and document quality control for technical writing to ensure consistent preparation of high-quality technical documents.
- Performs literature searches/reviews as necessary to obtain background information for development of documents.
- Manages the review and approval of documents needed for regulatory filings.
- Manages and communicates document-specific timelines to team members to ensure on-time deliverables are completed.
Education/Experience and Skills Requirements:
- A solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as FDA/EMA/ICH.
- A minimum of 3 years of technical writing experience in the biopharmaceutical industry plus a university degree in a life-science-related discipline, health-related field, is required OR an advanced scientific degree (PhD, PharmD, or MS) plus 2 years of technical writing experience in the biopharmaceutical industry.
- Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, and effectiveness.
- Demonstrated experience working with document contributors, including analytical experts, biostatistics, manufacturing operations and regulatory affairs to ensure appropriate collaboration and input into document development.
- Previous experience with and expert knowledge of cGMP guidelines is essential.
- Excellent attention to detail, communication, time management, organizational skills and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment.
- Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
- Self-starter and must function well under minimal supervision;
- Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat.
- Ability to effectively lead
- Ability to develop and execute strategies
- Handle issues appropriately and with a sense of urgency
- Strong leadership to support a multi-project environment in small biotech or large pharma
Ability to interact, cooperate and motivate across departments and functions
Location: New York, NY / Cranbury, NJ
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Search Firm Representatives Please Read Carefully
Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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