Genzyme - Massachusetts Biomedical Ops jobs

Biostatistician Senior - (Cambridge, Massachusetts)

Fri, 10 May 2013 16:00:00 GMT

Req Id: 32845

Biostatistician Senior-32845

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Sr. Biostatistician

The Sr.Biostatistician will be responsible for implementing and executing methodological and statistical aspects of clinical development programs. In addition, the Principal Biostatistician will provide leadership and guidance on statistical matters to interdepartmental clinical and regulatory teams. This position is open within Genzyme's Rare Disease therapeutic area and provides the opportunity to contribute during a regulatory review as well as working on new and exciting clinical studies.

Qualifications
Qualifications for this position include the following:

Ph.D (M.S) in biostatistics or statistics with 0-3 years of experience in a clinical trial setting (biotech, pharma, CRO, academic institution)Excellent communication and writing skills including the ability to clearly describe advanced statistical techniques and interpret results
Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
Thorough and up-to-date knowledge of advanced clinical trial statistical methodology, including time-to-event and recurrent event analysis, sequential methods, longitudinal data analysis (e.g. LME, GEE), techniques for handling missing data, nonparametric methods, Bayesian methods
Demonstrated productivity and ability to meet timelines for deliverables such as key results and final analyses
The ability to produce statistical documents such as publications or technical reports
Thorough and up-to-date working knowledge of SAS and additional statistical software (e.g. R, WinBUGS, etc.)
Understanding of clinical / regulatory concepts for at least one therapeutic area
With some supervision, ability to formulate statistical objectives, design and analyses for complex clinical projects
Good communication and developing negotiation skills

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Cambridge

Job Posting : May 10, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular

Medical Writer Senior - (Cambridge, Massachusetts)

Mon, 22 Apr 2013 16:00:00 GMT

Req Id: 32886

Medical Writer Senior-32886

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

This position is responsible for providing high quality clinical documentation to the Multiple Sclerosis (MS) business. The purpose of this job is to create and to manage creation by others of any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.

As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.

MAJOR DUTIES & RESPONSIBILITIES:
- Work with and lead project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines.
- Manage the project work of other medical writers (internal and remote) to prepare clinical regulatory documents. This includes training and mentoring in addition to participation in assessing workload, managing work assignments, and fulfilling administrative responsibilities.
- Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
- Ensure a consistent style of presentation of clinical document to maintain quality and ease of review.
- Contribute to Clinical Cluster, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate efficient development and submission of products.

Qualifications
Formal Education And Experience Required:
Experience (>3 years) as a regulatory medical writer, or equivalent, and presenting relevant specialist qualifications (e.g., MS, PhD in life sciences). Working knowledge of drug development, clinical research, basic statistics, and medical terminology; attentive to detail; able to work well independently and on teams; able to multi-task and meet deadlines; able to write English clearly, concisely, and at the level of a native speaker; effective in a multi-cultural environment. Experience working with teams to prepare clinical regulatory submission documents.

Knowledge And Skills Desirable But Not Essential:
Familiarity with written and oral French. Experience working on orphan diseases is desirable, as is submission experience with biological agents. Knowledge of drug safety, pharmacology, or relevant therapeutic areas

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Cambridge

Job Posting : Apr 22, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular

Director Medical Writing - (Cambridge, Massachusetts)

Wed, 17 Apr 2013 16:00:00 GMT

Req Id: 32726

Director Medical Writing-32726

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Director of Strategic Medical Writing

The Director of strategic medical writing is a vital member of the Global Scientific Communications and Publications team. A successful candidate will manage the development and on-time delivery of medical affairs as well as registry manuscripts and regulatory reports. This position will report directly to the head of Rare Diseases Scientific Communications and Publications.

The Director of medical writing supervises a team of medical writers to generate clinically focused communication including, manuscripts, abstracts, posters, and data presentations. This involves reviewing manuscript drafts and revisions and collaborating with internal or external authors. A key element of this role is to motivate, drive and encourage collaboration amongst authors to meet submission KPIs and to appropriately allocate resources.

Key Responsibilities:

o Manage contract writers who develop medical affairs and regulatory manuscripts as well as PMC regulatory reports originating from the Genzyme registries
o Manage medical writing budget within Rare Disease Sci Comm & Pubs cost center
o Liaise with product specific scientific communications leads to ensure that adequate medical writing resources are available to deliver projects on time
o Review and sign off on all registry regulatory documents, including regulatory reports and SAPs, protocols, patient authorizations, and other documents submitted to health authorities.
o Ensure that key scientific messages, based on the scientific platforms, are incorporated in all manuscripts, abstracts, and presentations
o Responsible for maintaining important KTL/author relationships to support timely publication development and submissions
o Ensure that contract writers develop, review, and QC all manuscripts and regulatory documents (from Genzyme registries) according to Genzyme SOPs.
o Ensure that all publications (manuscripts, abstracts, posters, presentations) are developed and reviewed in accordance with ICMJE and GPP guidelines and current Sanofi operational quality systems.
o Ensure that all publications are tracked and reviewed using Datavision, and undergo final global review and approval through Sanofi CLEAR system, in accordance with current SOPs.
o Participate in Rare Diseases Sci Comm core publication planning meetings
o Liaise with global clinical development teams, as needed, for registry projects that require input from these teams.

Qualifications

Basic Qualifications:

Doctorate degree (PhD, PharmD, MD) in life sciences and 5 or more years of Pharmaceutical/biotech industry experience
Demonstrated experience in project management and the successful preparation and submission of peer-reviewed manuscripts

Preferred Qualifications:

Outstanding written and verbal communication and interpersonal skills
Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus
Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams
Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines
Exemplary customer facing skills, and the capability to collaborate with Key Thought Leaders on publications and presentations, in a credible, responsive and customer focused manner

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Cambridge

Job Posting : Apr 17, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular

Statistician Manufacturing Technical Support - (Allston, Massachusetts)

Mon, 25 Mar 2013 16:00:00 GMT

Req Id: 32649

Statistician - Manufacturing Technical Support-32649

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Manufacturing Technical Support (MTS) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process. MTS is responsible for:

Providing daily on-the-floor technical support
Providing technical leadership in process-related investigations
Overseeing and leading data management & monitoring/SPC review processes
Leading process validation
Maintaining the Process Control Strategy and Operating Control Strategy
Identifying and implementing commercial process/product life cycle improvements
Defining relevant operational/technical standards and practices for the site
Identifying and driving implementation of improvements to maximize throughput and capacity utilization
Utilizing and maintaining robust scale down models to support manufacturing operations The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.

Demonstrates solid understanding and use of statistical principles and practices to solve a range of complex problems.
Performs complex statistical data analysis independently.

Provides subject matter expertise and guidance in support of SOPs, process, and technology.
Works with Corporate Statistics to ensure all statistical methods comply with regulations, guidances and standards published by FDA, ICH, EMA and other regulatory groups in project area.
Provides on-site statistical training.
Co-authors, reviews and/or approves SOPs, protocols and reports containing significant
statistical content with minimum supervision.
Maintains and demonstrates knowledge of state-of-the-art statistical practices and theories, and adopts them for successful completion of projects
Develops and applies understanding of R&D projects, assay development, and manufacturing processes.
May direct work of less experienced staff.
Leads small project teams as necessary.

Qualifications
Basic Qualifications:

Bachelor's degree in statistics/biostatistics/applied statistics and 5 + years of industrial statistical analysis experience OR Master's degree in statistics/biostatistics/applied statistics and 2 + years of industry experience OR PhD in statistics/biostatistics/applied statistics and 2 + years of industry or post-doctoral experience.
Strong technical writing skills
Experience communicating with cross functional teams
Proficient in Microsoft Word, Excel, PowerPoint

Preferred Qualifications:

In-depth statistical knowledge in R&D, Manufacturing, Quality and Logistics.
Statistical programming capability (e.g., JMP, SAS, R, Matlab, SIMCA).
Database programming capability (e.g. MS Access, Oracle)
Experience communicating with senior management
Experience providing solutions to difficult data issues M*

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Allston

Job Posting : Apr 22, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular

Associate Director Epidemiology\Biostatistics BDSI Registries - (Cambridge, Massachusetts)

Wed, 20 Mar 2013 16:00:00 GMT

Req Id: 32642

Associate Director Epidemiology/Biostatistics, BDSI Registries-32642

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Associate Director Epidemiology/Biostatistics, BDSI Registries

The Associate Director Epidemiology will provide leadership and support for the analysis of data from Genzyme's rare disease registries. The goals of the registries are to advance the understanding of the natural history of the disease and improve the long-term outcomes of treatment. This is an exciting opportunity involving a high-profile, high-impact rare disease registry program, and interesting and complex statistical and epidemiological analysis.
Key responsibilities:
· Work closely with the registry teams and external disease experts to lead the design and conduct of innovative epidemiological and biostatistical analyses, of both the natural history of the diseases under study, as well as long-term treatment outcomes
· Provide epidemiologic advice and direction for the design of new registry sub-studies, as well as the ongoing conduct of the registries.
· Present work-in-progress and final analyses via teleconference/WebEx meetings or in-person meetings to internal stakeholders, including Genzyme senior management, and external stakeholders, including international boards of scientific advisors.
· Interact directly with physicians, other health care providers, and health care payers and policymakers to develop hypotheses, analyses, and reports to address key clinical, scientific, and health policy questions.
· Develop analysis plans for implementation by Statistical Programming team
· Collaborate with Medical Writing team to prepare conference abstracts and manuscripts for publication in peer-reviewed scientific journals
· Provide internal and external training on the concepts and methods of epidemiology, as applied to rare diseases and their treatment.
· Management / mentoring of other Epidemiologists / Biostatisticians within the team
· Domestic and international travel required to participate Registry Board of Advisor meetings and other scientific conferences (~10% of time)

Qualifications
Basic qualifications:
· PhD / DSc / DrPH in Epidemiology /Biostatisitcs/Public Health
· At least 3 years of industry experience in pharma, biotech, or consulting environment
· Excellent oral and written communication skills
· Ability to work effectively in multidisciplinary teams
· Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods
· Experience and familiarity using SAS for statistical analysis
· Record of high quality publications in peer-reviewed journals.

M*

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Cambridge

Job Posting : Mar 20, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular

Medical Writer Principal - (Cambridge, Massachusetts)

Thu, 01 Nov 2012 16:00:00 GMT

Req Id: 30554

Medical Writer Principal-30554

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Visit www.genzyme.com.

This position is responsible for providing high quality clinical documentation to the Genzyme Rare Disease business. The purpose of this job is to create and to manage creation by others of any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.

As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.

MAJOR DUTIES & RESPONSIBILITIES:
- Work with and lead project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines.
- Manage the project work of other medical writers (internal and remote) to prepare clinical regulatory documents. This includes training and mentoring in addition to participation in assessing workload, managing work assignments, and fulfilling administrative responsibilities.
- Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
- Ensure a consistent style of presentation of clinical document to maintain quality and ease of review.
- Contribute to Clinical Cluster, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate efficient development and submission of products.

Qualifications
Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Detailed knowledge of requirements for preparation of key clinical regulatory documents (e.g., CSRs and CTDs.) Accurate and detail-oriented with excellent inter-personal skills. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.

Knowledge and Skills:
Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Detailed knowledge of requirements for preparation of key clinical regulatory documents (e.g., CSRs and CTDs.) Accurate and detail-oriented with excellent inter-personal skills. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.

Formal Education And Experience Required:
Substantial experience (8-10 years) as a medical writer, or equivalent, and presenting relevant specialist qualifications (e.g., Ph.D. in life sciences). Experience leading teams to prepare clinical regulatory submission documents, including CTD Module 2 summaries. Demonstrated experience mentoring and managing the project work of other medical writers.

Knowledge And Skills Desirable But Not Essential:
Familiarity with written and oral French. Experience working on orphan diseases is desirable, as is submission experience with biological agents. M*

Job : Biomedical Ops
Primary Location : United States-Massachusetts-Cambridge

Job Posting : May 3, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular