Medical Communications Manager
at Ronin Staffing

Date Posted: 10/27/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title:
Medical Communications Manager 
Pay: DOE
Location: Thousand Oaks, CA 91320
Length: 6 month contract + possible extension

Job Details:
Working with limited supervision, the successful candidate will be responsible for developing high quality, scientifically rigorous resources that adhere to internal guidelines, SOPs, policies and industry regulations within the oncology therapeutic area.

This will include, but not limited to:

  • Reviewing field-based promotional and educational materials for scientific accuracy as part of the Material Approval and Compliance (MAC)
  • Responding to escalations from the US call center to help address external customer questions regarding Amgen products and pipeline molecules
  • Developing de novo US Medical Content to be used in regional medical communications and/or regionalizing global GCC resources for Medical Information and Regional Medical Liaisons
  • Executing regional congress deliverables, disease state education programs and developing/adapting scientific content for online resources (e.g. websites, microsites, virtual congresses)
  • This role requires the ability to collaborate in a dynamic environment with multiple global and regional cross-functional teams, as well as to manage external providers and project-associated budgets.

Basic Qualifications:

  • Doctorate degree
    OR
  • Master’s degree and 3 years of clinical, academic, or industry experience
    OR
  • Bachelor’s degree and 5 years of clinical, academic, or industry experience
    OR
  • Associate’s degree and 10 years of clinical, academic, or industry experience
    OR
  • High school diploma / GED and 12 years of clinical, academic, or industry experience

Preferred Qualifications:

  • Doctorate degree (PharmD, PhD, MD, DO) with one or more years of cumulative experience in Medical/Scientific Affairs, Clinical Development, Clinical Research, patient care, and/or basic research.
  • Prior experience in Medical Affairs or Clinical Development within the biopharmaceutical industry (or clinical experience) in the Hematology/Oncology disease area
  • Understanding of Scientific Communications projects including disease state education programs, advisory boards, congress/publication plans, and RML resources
  • Understanding of Medical Information capabilities, literature surveillance, adverse event and product complaints requirements
  • Experience with marketed products and late-stage pipeline products
  • Excellent written, oral, and presentation skills and the ability to critically analyze the scientific literature to form logical opinions and communicate key business and clinical information at multiple levels
  • An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
  • The ability to work in teams and interface in a dynamic environment across corporate functions
  • Prior experience managing consultants and vendors is desired.

Top Must Have Skill Set:

  • Ideal: someone with oncology experience and ability to move between multiple projects.
  • Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing.
  • Sound project management and organizational skills.
  • Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation.

Day to Day Responsibilities:
The primary responsibilities may include, but are not limited to the following:

  • Management of R&D process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
  • Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with Subject Matter Experts. Note: these activities will usually take place virtually and across different time zones.
  • Liaison with other members of the QCA group (e.g. Business Process Modelers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts).
  • Management of documents via the established R&D Document Review process using the electronic document repository (Vault Quality).
  • Track and provide regular updates to process project inventory tool and to key Points of Contact

Job Snapshot

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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