Katalyst Healthcares & Life Sciences
Director- Medical Writing
Katalyst Healthcares & Life Sciences, Princeton, New Jersey, us, 08543
Job Description
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.The Director of Medical Writing, in partnership with the Client’s Clinical Development Team, is accountable for the timely delivery of high quality, regulatory-compliant documents spanning the clinical study process including but not limited to protocols, IBs, study reports, health authority briefing books and clinical summary documents for submissions across the Client Oncology portfolio. The scope of this position includes the management of both internal and external resources.
Responsibilities:
Accountable for delivery of clinical medical writing deliverables and objectives across the Client Oncology portfolio to quality, time and budget.
Work in close collaboration with Global Development Teams and Clinical Development to ensure alignment with program objectives.
Oversee the Clinical Protocol Review Process.
Lead, supervise, and manage performance of the global, internal medical writing team including development and succession planning.
Develop strategies and manage execution of external support for the internal team with Contract Research Organizations (CRO), or other external resources including in various locations globally.
Develop and manage medical writing resource and budget plans. Manage the functional budget.
Drive operational excellence of medical writing standards, processes, systems and tools.
Actively foster a can-do attitude to drive exceptional performance and continuous improvement.
Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to reporting activities.
Requirements:
Masters or Doctoral degree or equivalent in a medical/scientific discipline preferred.
8+ years of clinical research experience with 3+ years of experience in the development & management of a medical writing function and direct management of staff in a pharmaceutical and/or biotechnology environment. Oncology experience required.
Experience with writing and leading deliverables for global clinical trials and regulatory submissions.
Experience of direct management of staff in a pharmaceutical and/or biotechnology environment.
Experience partnering and managing CRO relationships and other external resources.
Proven excellence in operational strategy and demonstrated ability to execute operationally.
Excellent communication, planning and organizational skills.
Ability to inspire, to lead-by-example and motivate the team to seek solutions and get results.
Other Skills and Abilities:
Drives results
Strategic mindset
Manages ambiguity and complexity
Attracts and develops top talent
Effective oral and written communication skills required.
Teamwork and interpersonal skills required.
Highly detail and quality oriented.
Must be able to travel domestically and internationally. Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.
Language Skills:
Ability to review and present information effectively to internal and external clients, both domestic and international.
Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations related to data management activities.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret abstract and concrete concepts.
Computer Skills:
Solid PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at Client).
Physical Demands:
While performing the duties of this job, the employee is frequently required to sit, talk and hear.
The employee is occasionally required to walk.
The employee must utilize close vision and be able to adjust focus.
The noise level in the work environment is usually quiet.
Additional InformationAll your information will be kept confidential according to EEO guidelines.
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Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.The Director of Medical Writing, in partnership with the Client’s Clinical Development Team, is accountable for the timely delivery of high quality, regulatory-compliant documents spanning the clinical study process including but not limited to protocols, IBs, study reports, health authority briefing books and clinical summary documents for submissions across the Client Oncology portfolio. The scope of this position includes the management of both internal and external resources.
Responsibilities:
Accountable for delivery of clinical medical writing deliverables and objectives across the Client Oncology portfolio to quality, time and budget.
Work in close collaboration with Global Development Teams and Clinical Development to ensure alignment with program objectives.
Oversee the Clinical Protocol Review Process.
Lead, supervise, and manage performance of the global, internal medical writing team including development and succession planning.
Develop strategies and manage execution of external support for the internal team with Contract Research Organizations (CRO), or other external resources including in various locations globally.
Develop and manage medical writing resource and budget plans. Manage the functional budget.
Drive operational excellence of medical writing standards, processes, systems and tools.
Actively foster a can-do attitude to drive exceptional performance and continuous improvement.
Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to reporting activities.
Requirements:
Masters or Doctoral degree or equivalent in a medical/scientific discipline preferred.
8+ years of clinical research experience with 3+ years of experience in the development & management of a medical writing function and direct management of staff in a pharmaceutical and/or biotechnology environment. Oncology experience required.
Experience with writing and leading deliverables for global clinical trials and regulatory submissions.
Experience of direct management of staff in a pharmaceutical and/or biotechnology environment.
Experience partnering and managing CRO relationships and other external resources.
Proven excellence in operational strategy and demonstrated ability to execute operationally.
Excellent communication, planning and organizational skills.
Ability to inspire, to lead-by-example and motivate the team to seek solutions and get results.
Other Skills and Abilities:
Drives results
Strategic mindset
Manages ambiguity and complexity
Attracts and develops top talent
Effective oral and written communication skills required.
Teamwork and interpersonal skills required.
Highly detail and quality oriented.
Must be able to travel domestically and internationally. Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.
Language Skills:
Ability to review and present information effectively to internal and external clients, both domestic and international.
Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations related to data management activities.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret abstract and concrete concepts.
Computer Skills:
Solid PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at Client).
Physical Demands:
While performing the duties of this job, the employee is frequently required to sit, talk and hear.
The employee is occasionally required to walk.
The employee must utilize close vision and be able to adjust focus.
The noise level in the work environment is usually quiet.
Additional InformationAll your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr