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Delta Pharma is a professional services firm providing staffing and functional services principally focused on the life sciences vertical. Delta was founded in 1996 on the basic foundation of delivering industry leading staffing services to help our customers succeed. Our three core competencies encompass Clinical, Scientific and Technology staffing and functional services. Our services support clients with staffing needs including temporary contract, permanent placement, contract-to-hire, outsourced functional services and vendor management. Delta is a member of Randstad Professionals US and Netherlands-based Randstad Holdings NV, one of the world's largest staffing solutions company with a diversified portfolio of brands targeting a broad range of industry sectors in over 50 countries.
Delta Pharma works with proven industry leaders who value character, integrity and professional growth. We are committed to developing relationships that go beyond titles and reveal the core values desired by our clients in today's highly competitive search for talent. This successful approach is how the dedicated people of Delta Pharma match uncommon talent with extraordinary opportunities.
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Job Title
Position Description
- As a Lead Writer, will lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.
Position Responsibilities
- Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas and/or multiple projects
- Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents
- Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells
- Able to collaborate with project team to respond to health authority questions, requests
Benefits
- Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
Position Requirements
- PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
- Provide departmental management with adequate information to help assess resource needs
- Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
- Working knowledge of a document management system and basic knowledge of document publishing process
- Analyzed and interpreted complex data from a broad range of scientific disciplines
- Author regulatory documents (e.g. phase I/II clinical study reports, Investigator’s Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.
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