Director- Medical Writing
vor 3 Wochen
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
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-
Associate Director, Medical Writing
vor 3 Wochen
München, Deutschland Integrated Resources Inc. VollzeitAssociate Director, Medical Writing - Neuroscience Full-time Client is a Large Pharmaceutical Company The Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As...
-
Director of Medical Writing
vor 3 Wochen
München, Deutschland pathwayRP VollzeitEmTacq specializes in EM ployer T alent ACQ uisitions, matching the most qualified candidates with the most competitive positions available. We pride ourselves on not just putting bodies in seats, rather matching professionals to their careers. We are headquartered in the Raleigh / Durham, NC area. However, as a recruiting agencywe service companies...
-
Community Medical Director
vor 3 Wochen
München, Deutschland Quantix VollzeitJob Title: Medical Director Company located in Alameda, CA has an immediate need for a Medical Director for a direct hire position. This position reports to the Chief Medical Officer and will eventually have direct reports. The Medical Director is a member of the Medical Management Department of the health plan, and assists the Chief Medical Officer in...
-
Medical Director
vor 3 Wochen
München, Deutschland Quantix VollzeitJob Title: Medical Director Location: Alameda, CA Type: Direct Hire Job Description: Company located in Alameda, CA has an immediate need for a Medical Director for a direct hire position. This position reports to the Chief Medical Officer and will eventually have direct reports. The Medical Director is a member of the Medical Management Department of...
-
Director - Medical Affairs
vor 3 Wochen
München, Deutschland Integrated Resources Inc. VollzeitA Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide...
-
Global Medical Clinical Development Director
vor 3 Wochen
München, Deutschland Archer Hires VollzeitMedical Director Medical Affairs Oncology / Hematology Full-time Transition from medical practice to BioPharma Industry Clinical Physician Real work/life balance. Excellent compensation. Outstanding incentive/bonus programs. Medical Affairs Medical Director Oncology / Hematology The Medical Affairs Medical Director (MD) provides cross-functional leadership...
-
Medical Director/ Senior Medical Director
vor 2 Wochen
München, Deutschland European Foundation for the Care of Newborn Infants VollzeitThe European Foundation for the Care of Newborn Infants (EFCNI) is the first pan-European organisation and network to represent the interests of preterm and newborn infants and their families. It brings together parents, healthcare experts from different disciplines, and scientists with the common goal of improving longterm health of preterm and newborn...
-
Medical Director
vor 3 Wochen
München, Deutschland K.A. Recruiting Inc VollzeitMedical Director (1 hr from Phoenix, AZ) Full-time A licensed hospital located on a 13 acre campus that offers services for treatment of all stages of recovery from anorexia, bulimia, binge eating disorder, addictions and psychiatric disorders is looking for a Medical Director. Job Summary Ideal candidate will be a Psychiatrist with experience in...
-
Senior Medical Director
vor 3 Wochen
München, Deutschland North Star Staffing Solutions VollzeitSenior Medical Director -Oncology & Hematology Full-time As one of the most experienced staffing firms in Denver, Colorado, North Star Staffing Solutions prides itself on exceptional services and relationships that we have built over the years. Our dedication to satisfying our clients’ needs is driven by a passionate team of dedicated staff with over 10...
-
Medical Director Washington State
vor 3 Wochen
München, Deutschland Direct Staffing Inc VollzeitMedical Director Washington State Seattle Washington Exp 10-15 yrs Relo Bonus Occasional Travel Job Description Responsible for the administration of medical services for company health plans including the overall medical policies of the business unit to ensure the appropriate and most cost effective medical care is received and for the day-to-day...
-
Clinical Medical Manager
vor 3 Wochen
München, Deutschland MedCare Staffing VollzeitMedical Director Job Locum to Permanent Job MedCare Staffing represents a wide array of clients throughout the country, including small and medium-size medical facilities and practices specializing in physicians, nurse practitioners and physician assistants. Looking for a medical director job? Family Practice Medical Director for Atlanta/Tucker - part...
-
Psychiatrist Medical Director
vor 3 Wochen
München, Deutschland Direct Staffing Inc VollzeitResponsible for behavioral health leadership in the administration of behavioral health services for the health plan including the overall medical policies of the business unit to ensure the appropriate and most cost effective medical care is received and for the benefit of the member. Works closely with the Health Plan Chief Medical Officer in program...
-
Medical Director Pharmacovigilance
vor 3 Wochen
München, Deutschland Katalyst Healthcares & Life Sciences VollzeitKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and...
-
Director of Quality Innovation
vor 4 Wochen
München, Deutschland Life Science People VollzeitEngineering Director - Orthopedic Manufacturing Our Munich-based orthopedics medical device company is renowned for its innovative solutions and unwavering commitment to excellence. We're seeking an Engineering Director to lead our team. The Engineering Director will oversee engineering processes, ensuring compliance with regulatory standards while...
-
Director of Engineering
vor 4 Wochen
München, Deutschland Life Science People VollzeitJob Title: Engineering Director - Orthopedic Manufacturing Location: Munich, Germany Company Overview: Our Munich-based orthopedics medical device company is renowned for its innovative solutions and unwavering commitment to excellence. We're seeking an Engineering Director to lead our team. Position Overview: The Engineering Director will...
-
Global Medical Affairs Director
vor 3 Wochen
München, Deutschland 360 IT Professionals Vollzeit360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT...
-
Director Service Management
vor 3 Wochen
München, Deutschland Direct Staffing Inc VollzeitThe Unit Director is a professional nurse who manages the daily operations of a department (s) to provide services for patients while meeting quality, legal, organizational and medical staff goals. Responsible for promoting the efficient operations to provide effective nursing care of a designated department (s). Manages the department independently under...
-
Senior Medical Director
vor 2 Wochen
München, Deutschland European Foundation for the Care of Newborn Infants VollzeitThe European Foundation for the Care of Newborn Infants (EFCNI) is the first pan-European organisation and network to represent the interests of preterm and newborn infants and their families. It brings together parents, healthcare experts from different disciplines, and scientists with the common goal of improving longterm health of preterm and newborn...
-
Director of Marketing and Business Development
vor 3 Wochen
München, Deutschland North Star Staffing Solutions VollzeitDirector of Marketing and Business Development Full-time Our client, a multidisciplinary consulting firm in Hudson Valley, New York, is currently seeking a full-time Director of Marketing and Business Development. The Director will report to the President and work closely with senior leadership to lead the company’s marketing and business development...
-
Executive Director of Quality
vor 3 Wochen
München, Deutschland Thrive VollzeitThrive Recruiting finds top talent. Top talent creates a top company. Find your dream job with Thrive! Job Description POSITION PURPOSE The Executive Director of Quality has the responsibility for supervising the department of Quality Services . The Executive Director of Quality assures competent staff meets patient care and department needs,...
