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Clinical Scientist

Company: Merz Pharmaceuticals USA
Location: Raleigh
Posted on: June 13, 2021

Job Description:

Accountable for contributing scientific expertise to the trial-design phase of clinical projects under development

  • Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications.
  • Duties performed as a member of a cross-functional team of internal and external experts and in support of the medical director.
  • Projects are focused on devices, drugs, biologics, and/or other products for human use.
  • Projects may span from in-development to post-marketing studies and products.
  • Coordinate and integrate data and information from a variety of sources (e.g., internal and external studies, research documentation, and published literature) to support various clinical development initiatives.
  • Consolidate input from internal and external contributors to develop appropriate key messaging.
  • Support early-phase development activities, including curation, review, and interpretation of preclinical, exploratory data.
  • Provide scientific guidance and technical expertise within teams, across departments, and across functions by providing strategic, actionable direction, creating a strong sense of team unity and identity, and providing positive, constructive feedback.
  • Identify and troubleshoot study-specific issues, competing priorities, and clinical or scientific challenges.
  • Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management.
  • Support planning and preparation for internal and external stakeholder meetings (e.g., workshops/summits, investigator meetings, scientific advisory boards, and regulatory meetings).

Accountable for authorship of various clinical documents, including protocol synopses, protocols and amendments, and clinical study reports

  • Write, review, edit, and approve high-quality and timely clinical documents, contributing scientific/technical expertise related to clinical development and document preparation.
  • Demonstrate understanding and interpretation of data generated from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature and provide meaningful scientific interpretation and feedback to team members and other stakeholders.
  • Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plans.
  • Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures.
  • Proactively identify risks and escalate current/active/future issues; propose and enact solutions, developing contingency plans as needed.
  • Ensure the successful execution and presentation of critical documents to leadership.

Accountable for contributing scientific expertise to the trial set-up and execution phases of clinical projects, including results interpretation and reporting

  • Support, as a member of a cross-functional team, the preparation of additional trial-related documents (e.g., Informed Consent Form, Case Report Form, site-training materials) and other operational aspects of assigned studies.
  • Support and provide scientific input for activities related to data collection, cleaning, validation, and analysis, spanning from development / user-acceptance testing (UAT) of CRFs to review of data tables and listings.
  • Perform and/or support ongoing review of in-progress trial data and provide guidance for site-related questions.
  • Work with assigned biostatistician to anticipate necessary analyses and data tables to best present resultant data.
  • Evaluate and interpret trial data and results (tables, figures and listings) and align with key messaging with support from the project team.
  • Prepare/review data or other information for internal and/or external investigators (e.g., topline result summaries).

Accountable for contributing scientific expertise to regulatory activities

  • Provide scientific expertise for regulatory submission documents (e.g. meeting packages, investigational device exemption [IDE], investigational new drug [IND] applications, and sections of marketing applications [PMA/NDA/MAA/CTD] or other submissions depending on host country).
  • Support in-person, virtual, and written interactions with and submissions to regulatory bodies.

Accountable for contributing scientific expertise to product-maintenance activities

  • Provide scientific input for clinical parts of key regulatory and project documents (e.g., Clinical Evaluation Plan (CEP) and Report (CER), Instructions for Use, and Post-Market Clinical Follow-up Plan (PMCFP) and Report (PMCFR).
  • Provide scientific input for appropriate disclosure of clinical trial data in public registries.

Accountable for contributing scientific expertise to the presentation and publication of clinical trial results

  • Prepare and present trial data, to internal and external stakeholders, using clear, concise, and consistent result summaries.
  • Provide scientific and written expertise for manuscripts, abstracts, and poster submissions in collaboration with R&D, Medical Affairs, and Commercial colleagues.
  • Demonstrate knowledge of Good Publication Practices and editorial policies and apply expertise to publishing projects.

Accountable for providing oversight of external medical-writing vendors

  • Effectively manage assigned writing projects, including projects outsourced to
  • Oversee and review work of external writers to ensure Merz SOPs are followed, correct templates are used, and quality is maintained.

Accountable for supporting organizational development, compliance, and training

  • Participate in the development, improvement, and optimization of internal processes (e.g., workshops, taskforces, SOPs, work instructions, etc.), working toward efficiency and consistency.

Additional accountabilities

  • Establish general proficiency of applicable therapeutic area, gathering relevant product knowledge for application in assigned projects.
  • Contribute scientific expertise in support of business-development activities, including assisting in the identification and assessment of new opportunities.
  • Contribute scientific expertise in support of due diligence / in-licensing of products, including consultation with external experts.
  • Provide scientific input for aesthetic scale development and validation activities.

Education

  • Master's Degree in Life Sciences
  • PhD, DrPH, PharmD, etc.

Professional experience

  • At least 3 years of clinical-research experience, including design and conduct of clinical trials, in the pharmaceutical and/or medical device, health science, or biotech industry or equivalent combination of education, training, and experience.
  • Demonstrated competency in methodological development and review of clinical, regulatory, and scientific documents.
  • Demonstration of strong medical-writing skills (e.g., peer-reviewed publications; scientific presentations; IDEs/PMAs, IND/NDA modules, investigator brochures, study protocols, CSRs).

Knowledge, skills and abilities (incl. languages)

  • Demonstration of excellent verbal and written English, including understanding of English language usage in clinical/technical environments and standardized-writing
  • Demonstrated ability to develop and lead effective teams, capitalizing on individual and team strengths, to achieve objectives.
  • Demonstrated ability to foster constructive interactions, including conflict resolution, with various stakeholders.
  • Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155.
  • Understanding of clinical product development, clinical trials, and global regulatory submissions
  • Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of
  • Readily adaptable to changes in
  • Able to anticipate obstacles and proactively develop solutions to achieve project
  • Able to engage in an open, constructive, and continuous dialogue.
  • Able to develop solutions to complex problems that are consistent with company objectives.

Personal Skills

  • Sound organizational and planning skills; deadline-oriented and meticulous in approach; possess a sense of urgency, accuracy, and attention to detail.
  • Able to work independently and proactively
  • Solid work ethic, professionalism, and sense of responsibility and personal
  • Strong ability to work collaboratively and to respect other working cultures.
  • Team player with strong communication and presentation skills.
  • Prefers quality over quantity and is dependable.

Accountable for contributing scientific expertise to the trial-design phase of clinical projects under development

  • Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications.
  • Duties performed as a member of a cross-functional team of internal and external experts and in support of the medical director.
  • Projects are focused on devices, drugs, biologics, and/or other products for human use.
  • Projects may span from in-development to post-marketing studies and products.
  • Coordinate and integrate data and information from a variety of sources (e.g., internal and external studies, research documentation, and published literature) to support various clinical development initiatives.
  • Consolidate input from internal and external contributors to develop appropriate key messaging.
  • Support early-phase development activities, including curation, review, and interpretation of preclinical, exploratory data.
  • Provide scientific guidance and technical expertise within teams, across departments, and across functions by providing strategic, actionable direction, creating a strong sense of team unity and identity, and providing positive, constructive feedback.
  • Identify and troubleshoot study-specific issues, competing priorities, and clinical or scientific challenges.
  • Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management.
  • Support planning and preparation for internal and external stakeholder meetings (e.g., workshops/summits, investigator meetings, scientific advisory boards, and regulatory meetings).

Accountable for authorship of various clinical documents, including protocol synopses, protocols and amendments, and clinical study reports

  • Write, review, edit, and approve high-quality and timely clinical documents, contributing scientific/technical expertise related to clinical development and document preparation.
  • Demonstrate understanding and interpretation of data generated from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature and provide meaningful scientific interpretation and feedback to team members and other stakeholders.
  • Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plans.
  • Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures.
  • Proactively identify risks and escalate current/active/future issues; propose and enact solutions, developing contingency plans as needed.
  • Ensure the successful execution and presentation of critical documents to leadership.

Accountable for contributing scientific expertise to the trial set-up and execution phases of clinical projects, including results interpretation and reporting

  • Support, as a member of a cross-functional team, the preparation of additional trial-related documents (e.g., Informed Consent Form, Case Report Form, site-training materials) and other operational aspects of assigned studies.
  • Support and provide scientific input for activities related to data collection, cleaning, validation, and analysis, spanning from development / user-acceptance testing (UAT) of CRFs to review of data tables and listings.
  • Perform and/or support ongoing review of in-progress trial data and provide guidance for site-related questions.
  • Work with assigned biostatistician to anticipate necessary analyses and data tables to best present resultant data.
  • Evaluate and interpret trial data and results (tables, figures and listings) and align with key messaging with support from the project team.
  • Prepare/review data or other information for internal and/or external investigators (e.g., topline result summaries).

Accountable for contributing scientific expertise to regulatory activities

  • Provide scientific expertise for regulatory submission documents (e.g. meeting packages, investigational device exemption [IDE], investigational new drug [IND] applications, and sections of marketing applications [PMA/NDA/MAA/CTD] or other submissions depending on host country).
  • Support in-person, virtual, and written interactions with and submissions to regulatory bodies.

Accountable for contributing scientific expertise to product-maintenance activities

  • Provide scientific input for clinical parts of key regulatory and project documents (e.g., Clinical Evaluation Plan (CEP) and Report (CER), Instructions for Use, and Post-Market Clinical Follow-up Plan (PMCFP) and Report (PMCFR).
  • Provide scientific input for appropriate disclosure of clinical trial data in public registries.

Accountable for contributing scientific expertise to the presentation and publication of clinical trial results

  • Prepare and present trial data, to internal and external stakeholders, using clear, concise, and consistent result summaries.
  • Provide scientific and written expertise for manuscripts, abstracts, and poster submissions in collaboration with R&D, Medical Affairs, and Commercial colleagues.
  • Demonstrate knowledge of Good Publication Practices and editorial policies and apply expertise to publishing projects.

Accountable for providing oversight of external medical-writing vendors

  • Effectively manage assigned writing projects, including projects outsourced to
  • Oversee and review work of external writers to ensure Merz SOPs are followed, correct templates are used, and quality is maintained.

Accountable for supporting organizational development, compliance, and training

  • Participate in the development, improvement, and optimization of internal processes (e.g., workshops, taskforces, SOPs, work instructions, etc.), working toward efficiency and consistency.

Additional accountabilities

  • Establish general proficiency of applicable therapeutic area, gathering relevant product knowledge for application in assigned projects.
  • Contribute scientific expertise in support of business-development activities, including assisting in the identification and assessment of new opportunities.
  • Contribute scientific expertise in support of due diligence / in-licensing of products, including consultation with external experts.
  • Provide scientific input for aesthetic scale development and validation activities.

Education

  • Master's Degree in Life Sciences
  • PhD, DrPH, PharmD, etc.

Professional experience

  • At least 3 years of clinical-research experience, including design and conduct of clinical trials, in the pharmaceutical and/or medical device, health science, or biotech industry or equivalent combination of education, training, and experience.
  • Demonstrated competency in methodological development and review of clinical, regulatory, and scientific documents.
  • Demonstration of strong medical-writing skills (e.g., peer-reviewed publications; scientific presentations; IDEs/PMAs, IND/NDA modules, investigator brochures, study protocols, CSRs).

Knowledge, skills and abilities (incl. languages)

  • Demonstration of excellent verbal and written English, including understanding of English language usage in clinical/technical environments and standardized-writing
  • Demonstrated ability to develop and lead effective teams, capitalizing on individual and team strengths, to achieve objectives.
  • Demonstrated ability to foster constructive interactions, including conflict resolution, with various stakeholders.
  • Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155.
  • Understanding of clinical product development, clinical trials, and global regulatory submissions
  • Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of
  • Readily adaptable to changes in
  • Able to anticipate obstacles and proactively develop solutions to achieve project
  • Able to engage in an open, constructive, and continuous dialogue.
  • Able to develop solutions to complex problems that are consistent with company objectives.

Personal Skills

  • Sound organizational and planning skills; deadline-oriented and meticulous in approach; possess a sense of urgency, accuracy, and attention to detail.
  • Able to work independently and proactively
  • Solid work ethic, professionalism, and sense of responsibility and personal
  • Strong ability to work collaboratively and to respect other working cultures.
  • Team player with strong communication and presentation skills.
  • Prefers quality over quantity and is dependable.

Keywords: Merz Pharmaceuticals USA, Raleigh , Clinical Scientist, Other , Raleigh, North Carolina

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