Clinical Science Program Manager

Job Description

Who we want

• A scientific mindset . Has a scientific approach to medical questions and can effectively discuss complex information.

• A critical thinker . Can competently evaluate, interpret and analyze complex information and data.

• A medical writer . Excellent, evidence- based medical content creator with superior medical writing skills.

• A communicator. Thrives in a cross- functional environment communicating with teams across the organization.

• A team player . Dependable collaborative player who puts team success first.

What you will do

As a Clinical Science Program Manager, you will be working to Make Stroke History . Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. As a Clinical Scientist and a Medical Writer, you will make sure our devices have sufficient clinical evidence to place and keep them on the market. You will work directly with study investigators and regulatory agencies. You will use product knowledge and quick thinking to solve problems and will collaborate with regulatory teams on all phases of regulatory submissions and approvals, including clinical document preparation, formulation of responses to regulatory agencies and other regulatory documentation. You will drive a culture of continuous improvement in the Clinical Evidence Report (CER) medical writing processes. You will also collaborate cross- functionally to provide a CER strategy and develop strong CERs and related clinical regulatory documentation, incorporate new/update regulatory requirements, execute on critical strategic projects for publication, reimbursement or indication expansion.

You will represent Stryker Neurovascular as the subject matter expert within department for the Global product portfolio developing and maintaining in- depth therapeutic and product operation knowledge.

Your main job responsibilities are:

• Serves as medical writing lead on clinical regulatory documents such as those associated with filings and dossiers, including writing and maintaining Clinical Evaluation Reports. Works closely with the Clinical and Regulatory team(s) on document strategies.

• 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.

• Collaborates (writing, reviewing, editing and approval) with clinical, RD, quality assurance, safety, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing collaterals, PMCF reports and other documents that require the evaluation of clinical data and/or clinical literature.

• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory 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.

What you need

• MS or PhD in engineering, biological or life sciences, or Master s in Public Health, PMP/PgMP preferred

• 5- 8+ years of progressively increasing responsibility in clinical, medical writing or scientific field

• Medical device industry experience strongly preferred

• Experience of team management preferred

• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions

• Direct experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical evaluation reports and post market surveillance reporting.

• Applied knowledge of project management tools

• Demonstrated success in a team- based environment.

• Demonstrated interpersonal, written and oral communication skills.

Keyskills :
project managementagile program managementmanagement deliverypost market surveillance life sciencespublic health