Clinical Medical Affairs Program Manager de Virtual, Nevada em Stryker Corporation

Data de Postagem: 11/20/2019

Resumo do Emprego

Descrição do Emprego

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Clinical Medical Affairs Program Manager to join our Neurovascular Division to be in Fremont, CA or remotely anywhere in the US.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the 2016 FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 
  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and cross-functional teams.

What you will do

As a Clinical Medical Affairs Program Manager, you will provide advanced scientific writing expertise to the regulatory, clinical and other functional area teams, ensuring successful preparation of high-quality submission-ready documents and marketing medical materials, which includes developing and maintaining Clinical Evaluation Reports (CERs), addressing Regulatory Body questions requiring clinical data support and collaborating on a number of other clinical and regulatory documents. You will serve as the scientific writing content expert for the department. You will be the clinical science liaison with internal customers and regulatory agencies regarding product safety and performance.

Clinical Regulatory Management:

  • Serves as medical writing lead on clinical regulatory documents such as those associated with filings and dossiers, including writing and maintaining CERs.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects.
  • Collaborate with RA on all phases of regulatory submissions and approvals, including clinical document preparation and review, the formulation of responses to regulatory agencies and other clinical regulatory documentation.
  • Drive a culture of continuous improvement in the Medical Writing processes, incorporating new or updating regulatory requirements.

Medical and Technical Writing:

  • Coordinate the completion of clinical science documents including writing study reports.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects.
  • Collaborate with other teams on clinical study reports, clinical evidence gap assessments, marketing collaterals, PMCF reports, systematic literature searches, publications and other documents that require the evaluation of clinical data and/or clinical literature.

Clinical Evidence Expertise:

  • Serves as a subject matter expert within the department for the Global product portfolio; develops and maintains in-depth therapeutic knowledge and applies it to the development of well written clinical evidence documents;
  • Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables.

Project Management:

  • Responsible for effective communication among team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).

Communications Management:

  • Provide program updates to management. Respond to clinical science questions/inquiries from internal customers and regulatory agencies.
  • Collaborate with cross-functional team to assure high quality and successful project delivery.
  • Represents Clinical on cross-functional product development core teams and oversee clinical advisory boards to guide clinical strategy.

Business Acumen:

  • Understand generally the strategic objectives of senior leaders and use those levers to drive program decisions. Contribute to strategic growth decisions and initiatives. Partners with cross-functional managers in developing functional strategic initiatives.

What you need

  • A Bachelor’s Degree in a Scientific discipline required.
  • An advanced degree in Biomedical Sciences or technical discipline preferred.
  • A PMP/PgMP certificate preferred.
  • A minimum of 10 years of Clinical Research experience in Medical device or related industry required or possession of an advanced degree with a minimum of 5 years of Clinical Research experience in the Medical device or related industry required.
  • Previous Regulatory experience and familiarity with current regulatory agency guidance and regulations, including EU MDR and MEDDEV Rev 4 preferred.
  • Knowledgeable in clinical operations, risk management, regulatory submission and US and international guidelines preferred.
  • Previous experience with Medical Device industry or related industry experience required.
  • Direct experience with medical and/or scientific writing within a medical device industry or related industry including Clinical Evaluation Reports (CER) and post market surveillance (PMS) reporting required.
  • Applied knowledge of project management tools.
  • Demonstrated success in a team-based environment.
  • Demonstrated interpersonal, written and oral communication skills.

Work From Home: Remote

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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