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Senior Medical Writer

Company: Syner-G BioPharma Group
Location: Southborough
Posted on: November 26, 2022

Job Description:

Are you a Medical Writer who enjoys authoring, editing, and reviewing scientific and regulatory documents that progress therapeutics aimed at improving health outcomes and saving lives? Would you like the opportunity to participate on a variety of documents across many therapeutic areas? If so, we are looking for experienced Medical Writers to join our growing team and would love to hear from you! In this client-facing role, you will work collaboratively with IMPACT team members to author, edit, and review documents such as clinical study reports (CSRs), subject narratives, clinical sections of INDs, NDAs and BLAs, protocols, and/or briefing documents. In addition to independently writing documents, you may serve as a project manager for more complex writing projects and act as a mentor to train and develop early-in-career medical writers. This is a great opportunity for an experienced Medical Writer who would like greater exposure to a variety of clients, document types, and therapeutic areas. Your background

  • PhD, PharmD or MD in life or health sciences and approximately 3 years of regulatory medical writing experience in a pharmaceutical company, contract research organization (CRO) or comparable organization; or,
  • Undergraduate degree in life or health sciences and approximately 3-5 years of regulatory medical writing experience in a pharmaceutical company, CRO, or comparable organization. Your skills and abilities
    • CRO/Pharma industry knowledge; current best practices and regulations for the scientific documents noted above, drug development cycles, and regulatory standards.
    • Experience with independently authoring CSRs, Protocols and Submission Documents, such as IND components and/or NDA components (Integrated Summaries and Clinical Summaries).
    • Strong analytical skills; ability to understand and interpret complex clinical and scientific data and formulate those data into a well-thought out and reviewer friendly manner.
    • Clear written communication skills; ability to present written results in an understandable manner to a variety of audiences.
    • Excellent verbal communication skills; experience with leading and facilitating discussions with internal project teams and clients/sponsors (such as roundtable meetings.)
    • Strong attention to detail; experience with Quality Control (QC) and editing of scientific documents.
    • Collaborative project management skills; demonstrated ability to prioritize multiple projects and timelines.
    • Broad software proficiency; strong knowledge of MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat. Your responsibilities
      • Independently author and review a broad range of clinical, scientific, and regulatory submission documents within a team environment. Documents include, but are not limited to CSRs, subject narratives, clinical sections of INDs, NDAs and BLAs, protocols, and/or briefing documents.
      • Contribute to the development of client timelines; contribute to and facilitate internal and client meetings.
      • Mentor, train, and coach early-in-career medical writers.
      • Perform internal document reviews, editing, and QC as needed. Who we are Impact Pharmaceutical Services, LLC (IMPACT) is a CRO located in Research Triangle Park, NC, that specializes in providing a range of drug development services for the pharmaceutical and biotech industries, including medical writing, QC, regulatory affairs, regulatory operations, and project and program management. At IMPACT, our goal is to produce high-quality deliverable documents that are sound from both scientific and regulatory standpoints for every client on every project. Our experienced employees and our honest, transparent, and flexible approach have led to trusted, long-lasting relationships with our clients, who consider us an extension of their project teams. As an employee, you will experience us leading with our core purpose, "To develop and inspire pharmaceutical professionals," and through our core values of quality, integrity, flexibility, and responsiveness. We encourage open, two-way communication throughout the company and provide a supportive and encouraging working environment that allows employees to reach their greatest potential. At IMPACT, we realize the vital role a positive work/life balance plays in establishing a rewarding, productive, and long-term career. As a result, a flexible, family-friendly work environment is a key element of our culture and is one of the reasons people want to work (and stay) here! We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit plans, and ongoing recognition and career development opportunities. Employees also enjoy our generous paid time off program, paid holidays, flexible working hours, and fully remote work option. Impact Pharmaceutical Services, LLC is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. IMPACT is an E-Verify employer.

Keywords: Syner-G BioPharma Group, Boston , Senior Medical Writer, Advertising , Southborough, Massachusetts

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