About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

The Medical Information Associate is the primary contact in Medical Information to respond orally or in writing to medical and drug information questions regarding EMD Serono products to health care professionals and consumers. This includes responsibility for all processes related to receipt, response, resolution and documentation of these inquiries, within company standard operating procedures, regulatory requirements, and legal guidelines. The Medical Information Specialist is also responsible to document and triage reports of adverse events, product complaints, or other non-medical information inquiries or issues to the appropriate EMD Serono department.

KEY TASKS AND RESPONSIBILITIES:

• Handles telephone and written communication from healthcare professionals, patients, and the general public.
• Provides complete, timely and accurate oral and/or written responses to unsolicited requests for medical and drug information that can include information within or beyond product labeling and promotional materials(i.e., on- or off-label).
• Prepares customized written responses that can incorporate standard response documents, literature searches, and/or articles in collaboration with Medical Information Specialists in accordance with department processes and company, industy, regulatory, and legal guidelines and requirements.
• Assures payment of appropriate copyright fees to reduce legal risk to EMD Serono.
• Monitors incoming inquiries to minimize regulatory and compliance risk to EMD Serono.
• Obtains necessary documentation of unsolicitation of the request.
• Monitors EMD Serono field-based personnel affiliation with submitted requests.
• Documents in a timely manner in IRMS (Information Request Management System) all inquiries and responses and other actions associated with an external or internal customer within Medical Information.
• Documents and validates in IRMS all medical, scientific, and other inquiries received by the after-hours medical information provider.
• Receives, documents, and transfers adverse event or product complaint reports to US Product Surveillance and Quality Assurance.
• Receives, documents, and triages inquiries unrelated to medical information to the appropriate EMD Serono department.
• Provides basic information on EMD Serono clinical trials to prospective study subjects and investigators.
• Prepares scheduled and develops ad hoc written reports from IRMS for trend analysis and tracking of inquiries received and responses delivered by Medical Information.
• Liaises with Therapeutic Area Contact Center to align, where appropriate, work processes, call scripts, and training with those of Medical Information.
• Creates and maintains verbal standard responses in collaboration with Medical Information Specialists.
• Maintains knowledge that impacts the drug information and safety of all EMD Serono products, including literature, industry reports, and regulatory developments.
• Alerts the appropriate therapeutic area business team of unusual trends or potential opportunities based on inquiries received.

Qualifications

EDUCATION & LANGUAGES

• Healthcare degree (e.g., R.N, R.Ph., Pharm.D) preferred.
• B.S. in an appropriate scientific major considered

PROFESSIONAL SKILLS & EXPERIENCE

• 1-3 years pharmaceutical-related industry experience in medical information and communications preferred.
• Familiarity with medical terminology, medical literature, clinical research and documentation.
• Other relevant experience considered (e.g., clinical pharmacy, clinical research, medical affairs, drug safety, hospital, drug information centers, call centers).

PERSONAL SKILLS & COMPETENCIES

• Excellent oral and written communication skills to communicate professionally to healthcare professionals and patients.
• Innovative approach to problem solving and solution orientation.
• Proficiency in MS Office applications with knowledge of databases.
• Experience with Lotus Notes and Information Request Management System (IRMS) is desirable.
• Organizational skills and ability to follow projects to completion while adhering to company, regulatory, and legal guidelines and requirements.

Click the link below and open the door to the future by submitting your resume today!

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

EMD Serono is seeking to appoint a motivated and well qualified scientist for the Protein Engineering and Monoclonal Antibody Technologies (PEAT) group within New Biological Entities (NBE) Technologies. He/she will be responsible for the Monoclonal Antibody Engineering needs of the group and head up a laboratory staff of three with a potential to grow.

This individual will report to the Head of PEAT at their facility in suburban Boston and will be part of an energetic team in a key strategic area of the Discovery organization within EMD Serono. In this regard, he/she will play an important role in the overall responsibility of NBE Technologies for the discovery, optimization and progression of the Company's biotherapeutics discovery pipeline.

As Scientist - Antibody Engineering the incumbent will have responsibilities including, but not limited to, the following:

• Leading a group of scientist and technicians in the Monoclonal Antibody Engineering laboratory
• Assuming responsibility for the humanization and optimization of antibody candidates generated by hybridoma- or phage display-technology.
• Managing the group and taking responsibility for its projects by driving and coordinating his/her direct reports in achieving the specific objectives of the respective research projects.
• Advancing antibody technologies within his/her own group as well as influencing the strategies on current and future technologies.
• Representing the monoclonal antibody department in specific antibody project teams.
• Taking responsibility for defining requirements for research projects and identifying potential constraints and risks.
• Use of problem solving skills in evaluating issues, and monitoring and initiating corrective actions where necessary.
• Taking responsibility for proposing new projects or amendments to existing projects to the Head of PEAT in the US.

• The ideal candidate will have a Ph.D. in molecular biology, biochemistry, biotechnology or biological sciences.
• This individual will be a highly motivated scientist with a proven track record in antibody engineering and must have several years of post-doctoral experience in an academic or industry setting.
• A strong background in molecular biology, with extensive experience in antibody engineering, antibody expression and purification, and biochemical and biophysical methods for the analysis of antibodies is required. An interest to work part-time at the laboratory bench is desirable.
• Familiarity with antibody phage display technology and affinity maturation, and interpretation of computational modelling of antibody-antigen interactions would be useful. Further, experience in preclinical development of therapeutic antibodies is desirable.
• It is desired that the candidate demonstrate an aptitude to interact constructively with others across multiple cultural backgrounds in a dynamic matrix structure. He/she must have the ability to collaborate with colleagues throughout the organization in research functions i.e., bio-informatics, protein and cell sciences and structural biology and in corporate functions i.e., business development, intellectual property.
• Further to this the candidate will possess strong communication skills, both oral and written. He/she should be confident in presentation with parties both small and large.
• As leader of a group, the candidate must be committed to its members and foster a teamwork approach. This will partially be accomplished through the facilitation of a positive work environment. He/she should be skilled in motivating and coaching others as well as interacting well in a team.
• The candidate will be, above all, a proactive self-starter with a positive "can do" attitude. He/she will have demonstrated success in achieving goals, be strongly results oriented and have the ability to drive tasks through to completion.
• The incumbent will be required to focus on multiple issues at one time, and must have the ability to organise and direct diverse activities in a changing environment, often under time pressure.
• With a mature, self-confident and well-balanced personality, it is essential that the candidate also possess a high standard of ethical and intellectual integrity.
• Finally, the candidate must be strongly computer literate.

EMD Serono, Inc. Named as a Top Employer by Science Magazine

• more

 

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

• Independently program (or write validation programs for) and document tables/listings/graphs for clinical trials or portions of clinical trials requiring routine data manipulation and analysis.
• Routine data manipulation and analysis with limited direction.
• Program (or write validation programs for) and document tables/listings/graphs for clinical trials requiring complex data manipulation and analysis.
• Provide input into general standardization efforts and create (or validate) global macros that streamline repetitive operations.
• Mentor biostatisticians and statistical programmer/analysts with advance SAS programming techniques.
• Interface with SAS technical support to resolve software problems.
• Coordinate, validate and implement SAS upgrades and licenses.
• Independently provide input into CRF specifications to collect data specified in the protocol and query with SAS technical support to resolve software problems, coordinate, validate and implement SAS upgrades and licenses.
• Independently provide input into CRF specifications to collect data specified in the protocol and query check specifications and provide input into analysis plan specifications and data presentations for clinical trials requiring complex data manipulation and analysis.
• Independently program (or write validation programs for) patient randomizations.
• Independently create (or validate) non-standard complex derived datasets.
• Create project and study phase sub-directories ensuring that all project work resides in the correct project and study phase sub-directories.
• Validate study phase flags in oracle tables and download study phase records from oracle tables to create analysis datasets.
• Audit changes to the database between study phases.
• Understand and follow all statistical and statistical programming SOP’s as well as any other relevant SOP.
• Lead process improvement teams as required.
• Effectively communicate analysis specification and programming/data issues that arise prior to or during analysis in a timely manner.

• MS, BS (or equivalent).
• 6 years pharmaceutical/biotech or other relevant experience.
• Fundamental knowledge of relevant statistical areas.
• Fundamental knowledge of relevant clinical areas.
• Advanced knowledge of SAS/Bas, SAS/STAT; knowledge of SAS/Connect, SAS/Macro, SQL.
• Excellent communication skills
• Ability to independently solve complex problems logically.

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

• Function as a project biostatistician coordinating statistical aspects across clinical trials within a specific project in a therapeutic area
• With limited direction, provide statistical input for statistically complex protocol development
• With limited direction, write statistical analysis plans and perform statistical analyses for statistically complex clinical trials
• With limited direction, write statistical analysis plans and perform statistical analyses for safety and efficacy summaries for regulatory submissions
• Independently provide statistical input for statistically routine protocol development
• Independently write statistical analysis plans and perform statistical analyses for statistically routine clinical trials
• Participate in departmental standardization efforts
• Provide support towards statistical research

• Participate on clinical development teams
• Provide statistical input into clinical development plans
• With limited direction, participate in the development of statistical standards for clinical development programs
• Review statistical analysis plans written by other statisticians on the project
• Review statistical analysis results produced by other statisticians on the project
• Review statistical methods sections and the interpretation of results written by other statisticians on the project
• Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation

• With limited direction, provide statistical input for protocol/CRF development (e.g., trial design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough evaluation of results section; effective CRF specifications to collect data specified the protocol)
• With limited direction, write statistical analysis plans for clinical trials as well as for integrated safety and efficacy summaries. Analysis plans written include the most appropriate statistical methodology and data presentations.
• With limited direction, analyze clinical trials
• With limited direction, write accurate, logical, clear, concise, thorough and objective statistical methods sections for clinical trial reports
• Review and co-author clinical trial reports ensuring the accuracy of the statistical interpretation
• Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WIs/SOPs. Provide input into all newly developed departmental quality documents
• Provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations)
• With direction, interact with regulatory agencies regarding statistical issues
• With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context
• Participate effectively on clinical trial teams
• With direction, provide solutions for complex issues presenting alternatives and identifying the best solution
• With limited direction, communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner
• With limited direction, function as the statistical primary contact with CROs for studies that are outsourced, and ensure the accuracy and timeliness of the CROs analysis alerting management to any unforeseen circumstances
• Produce assigned work within the timelines provided ensuring deadlines are met

• Ph.D. or MS in statistics, biostatistics or related discipline
• Fluent in English (French or German is a plus)

• Several years experience in the Pharmaceutical/Biotechnology industry
• Working SAS knowledge and proficient in SAS/Stat
• Knowledge of ICH Statistical and Clinical Report Guidelines
• Familiarization with relevant therapeutic areas

• Ability to work in a matrix organization
• Ability to work with multi-disciplinary groups
• Strong communication, negotiation and issue resolution skills
• Balance concurrent tasks and responsibilities

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

The Category Manager is responsible for managing a portfolio of Commercial/Marketing spend categories within a bio-pharmaceutical organization. As a key link between internal customer departments, Procurement, and EMD Serono's external supplier base, the Category Manager is accountable for understanding key business drivers and ensuring that customer requirements are fulfilled. Extensive cross-functional collaboration, and use of strategic sourcing best practices are keys to maximizing value in terms of cost savings/avoidance, risk reduction, quality and supplier performance. The role holder conducts internal and external spend and market analyses, identifies opportunities, develops category strategies, leads sourcing teams, negotiates contracts and manages key supplier relationships. The role holder is an energetic, flexible team player capable of forming strong relationships throughout the entire organization, in addition to successfully leveraging resources, processes and tools to achieve desired outcomes.

KEY TASKS AND RESPONSIBILITIES

• Actively work with the business partners to source goods and services in accordance with policies and procedures.
• Develop subject matter expertise in order to enhance ability to add value from a procurement perspective.
• Ensure the timely execution and delivery of products and services in accordance with business timelines.
• Drive value, service and cost savings through optimum vendor selection, management and effective negotiation.
• Lead the supplier performance management process for assigned categories.
• Provide strategic insight and access to all relevant spend and related data.
• Ensure that the business area engages and fully supports the supply base and supplier management strategies that impact their business area.

• Willing to diplomatically challenge concepts and tackle large, complex tasks.
• Active external learner - can identify new and better ways, and takes advantage of ideas, best practices and solutions
• Ability to support/lead and affect transformational change effort
• Customer focus and successful management of many internal customers and competing priorities and the need to continually allocate and balance resources across projects, or Account Planning
• Strong skills in strategic influencing, collaboration, communications, and conflict management
• Strong spend and supplier analysis skills

EDUCATION/PROFESSIONAL EXPERIENCE

• Bachelor's degree required (Master's degree preferred)
• 8 years of relevant work experience with strong preference in a large multi-national bio-pharmaceutical organization
• At least 5 years experience in strategic sourcing/category management, conducting cross-functional sourcing projects and negotiating contracts for complex services, Project background in most, if not all, key categories of bio-pharmaceutical commercial spend (i.e., Agency, Media, Market Research, Medical Education, Conferences, Print, Premiums and Direct Marketing)
• Strategy development experience
• C.P.M. or CPIM certificate preferred

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

The representative of Toxicology at the R&D hub in Billerica, MA, USA, serves as the interface between discovery teams and the global safety function. He/she represents toxicology on those teams and ensures high quality drug candidates in respect to their non-clinical safety profile. He/she also supports development projects with focus on the USA.

Functional Tasks

• Serve as the interface between discovery teams at the R&D hub in Billerica and the global toxicology function
• Support discovery activities with high quality toxicology input
• Support development activities for compounds with focus in the USA with toxicology expertise
• Prepare internal and external (e.g. IND) documents supporting the advancement of drug candidates in the pipeline
• Participate in and contribute to internal and external meetings related to drug candidate discovery and development

• DVM, MD, PhD in a life science field, or comparable education
• DABT or eligible for DABT status, or comparable certification
• English (oral and writing), German desirable

• Profound knowledge and expertise in pharmaceutical compound (NCE and NBE) toxicology and non-clinical safety assessment in general
• Experience in early toxicological assessment and testing of drug candidates
• Knowledge and experience in drug development with special emphasis on non-clinical safety

Teamwork

• Strong teamwork skills are essential as the major focus of the position is working in and with teams

• Relates to internal customers, e.g. discovery teams, development functions, and external customers, e.g. FDA
• Communication with Impact
• Excellent communication skills and a high level of persuasive power backed by excellent scientific expertise are required for dealing with both internal and external customers

• Being located at an R&D hub with, however, the major parts of the own organization located on a different continent requires a deep understanding of strategic necessities in a global organization

• Discovery project support in particular requires innovative approaches with case by case tailored assessment packages

Awards & Recognition

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

In this role you will make a significant contribution to the Consumer Marketing Team for a product that has the potential to meet a significant unmet need for people living with MS. During the pre-launch period ensure the tactical plan is implemented effectively so the appropriate promotional and educational materials are prepared for drug approval. as well as contribute to the development of promotional materials and consumer programs / initiatives based on clinical data and other key selling points relevant to patients.

KEY TASKS & RESPONSIBILITIES

• Think with a "patients first" attitude in the development and execution of marketing tools, programs, and services that fulfill strategies which include, but are not limited to live patient programs, development of patient educational content & tools via the web and traditional modalities, patient ambassador development and patient tools/kits
• Own and execute specific initiatives within the consumer tactical plans for the brand
• Ensure consumer messaging is built into all promotional activities
• Work closely with Senior Product Manager to implement highly interactive patient Consumer Relationship Management program
• Use social media and web assets to increase patient awareness and relationships
• Iterate and refine initiatives and programs taking into consideration the changing competitive landscape including other emerging therapies, new clinical data, and emerging market research findings. Work with the Senior Product Manager of Consumer Marketing to ensure that these initiatives fit with the overall strategy.
• Work with legal, regulatory and medical committee to ensure approval of assigned marketing collateral
• Work in close collaboration with business intelligence and market research on the development of research tools and analysis of results to better refine consumer programming and initiatives.
• Work in close collaboration with field sales management and patient service center to ensure successful development and implementation of programs, tools, and services
• Work with Marketing Advisory team to develop and adapt plans, support implementation of new and unique customer programs, and value-added services, etc.
• Conduct field visits as necessary to evaluate effectiveness of marketing programs, tools and services.

EDUCATION & LANGUAGES

• BA/BS required
• MBA or advanced degree preferred

• A minimum of three years related marketing experience in pharmaceutical/biotech industry
• Expertise in digital media, web for patient audience
• Experience in developing patient educational programming preferred
• Strong pharmaceutical marketing experience with consumer audience preferred
• Familiarity and experience with patient ambassador programs preferred
• Experience with Customer Relationship Management Programs
• Experience working with vendors and contractors,li>Previous pharmaceutical sales or market research experience a plus

• Strong communication skills and an ability to translate medical information into succinct and high impact marketing messages for consumer audience
• Understanding of patient educational needs
• Ability to work in fast paced environment
• Ability to analyze competitive landscape and key brand issues and ascertain best use of brand budget on consumer audience
• Must be comfortable with ambiguity common in pre-launch environment
• Have the ability to multi-task and have superior organizational skills
• Excellent interpersonal skills
• Ability to access and influence various functional areas and motivate groups to actions through team building initiatives
• Leadership skills in a matrix, and/or co-promote environment,li>Collaborative work style and familiarity with core operating function (sales, marketing, regulatory, legal, medical, global marketing and co-promotion partners)
• Business oriented thinking
• Strong PowerPoint and excel knowledge
• Strong Presentation skills
• Relationship Management Skills
• Position requires both domestic and international travel up to 30-40% of time. Some domestic travel peak times in the first few months of this role may be up to 60%.

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

• Support the preparation of regulatory documentation for submission to regulatory agencies
• Regulatory Agency liaison for CTAs/INDs and maintenance activities.

• Regulatory Project Team Member for smaller project, e.g. Life cycle management project
• Regulatory Affairs sub-team member.
• Trial Team member
• Prepare regulatory documents
• Review of protocols and some regulatory documentation

• Constitute and manage Regulatory Subteam if Regulatory Project Team Member
• Manage and prepare CTAs WW until approval of particular studies
• Act as agency liaison for CTAs/INDs and maintenance activities

EDUCATION/LANGUAGES

• Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
• Excellent spoken and written English

• Minimum of 5 years' industry experience of which at least 3 years' regulatory experience
• Experience in preparation and submission of parts of a submission in at least one ICH region and clinical trial applications (WW)
• Experience in project team membership
• Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
• Experience with regulatory maintenance activities for authorizations in a local affiliate or head office

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

• Support the preparation of regulatory documentation for submission to regulatory agencies
• Regulatory Agency liaison for CTAs/INDs and maintenance activities.

• Regulatory Project Team Member for smaller project, e.g. Life cycle management project
• Regulatory Affairs sub-team member
• Trial Team member
• Prepare regulatory documents
• Review of protocols and some regulatory documentation

• Constitute and manage Regulatory Subteam if Regulatory Project Team Member
• Manage and prepare CTAs WW until approval of particular studies
• Act as agency liaison for CTAs/INDs and maintenance activities

EDUCATION/LANGUAGES

• Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
• Excellent spoken and written English

• Minimum of 5 years' industry experience of which at least 3 years' regulatory experience
• Experience in preparation and submission of parts of a submission in at least one ICH region and clinical trial applications (WW)
• Experience in project team membership
• Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
• Experience with regulatory maintenance activities for authorizations in a local affiliate or head office

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more

About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

Responsible for timely document management of all electronic submissions to FDA for marketing materials and associated internal electronic and paper record keeping in accordance with regulatory requirements and procedures. Prepare USRA promotional reviewers for weekly review meetings by coordinating their agendas, obtaining and organizing materials prior to review meetings in accordance with promotional and scientific review policy. Administrative duties as assigned.

KEY TASKS & RESPONSIBILITIES:

• Under the supervision of the USRA Managers/Directors, generate and track commercial labeling implementation requests using Trackwise (or equivalent Database for the Change control process - CCP) for assigned products. Coordinate timely review and approval. Organize, maintain, and retrieve records associated with past and ongoing labeling reviews. Assist with manual or electronic label checks.
• Proactively monitor and manage Mgr/Director promotional review weekly review assignments. Print and organize Promotional and Scientific Review Committee materials for Regulatory reviewers in accordance with meeting agendas
• Organize and maintain historical, current and future labeling pdf files and inventory of originals past and present for assigned products. Maintain chronology of labeling history and provide back-up for other products.
• Maintain restricted access database for labeling, communicate labeling changes to stakeholders and conduct periodic checks of marketing materials for correct labeling for assigned products.
• Ensure that all incoming and outgoing submissions and government communications and documentation are formally received into the Document Control Room, indexed and properly filed in a timely manner.
• Distribute incoming and outgoing governmental correspondence maintaining appropriate level of confidentiality.
• Maintain PC-based and local area network (LAN) regulatory affairs databases including NDC-UPC codes, labeling pdf files for assigned products
• Prepare and QC paper and electronic FDA submissions including 2253s for promotional labeling and advertising materials for assigned products. Provide back-up as needed for other products.
• Maintain paper and electronic regulatory labeling and FDA communication files and update of regulatory databases and tracking tools (e.g., Mephisto, Trackwise), generate reports and presentations, preparetravel expenses, check requests, set-up meetings, order department supplies
• Provide back-up to Senior Regulatory Affairs Coordinator
• Other duties, as assigned.

EDUCATION/LANGUAGES

• Associates Degree or equivalent in industry experience. Experience with pdf, adrobe writer, SPL desirable.
• Experience Document Management and Control processes highly desirable

• 2 to 5 years of industry experience in a pharmaceutical or regulatory role.
• Basic understanding of the copy review process and prescription labeling requirements for drugs and devices.
• Knowledge of FDA regulations for labeling, promotion and submissions.
• Highly organized, proactive, and proficient in using personal computer, i.e., Word, Excel, Powerpoint, Acrobat Writer, Lotus Notes, and ability to learn process-oriented databases for labeling and materials review: Datavision, Trackwise, Alfresco

• Solid analytical and problem solving skills.
• High level of professionalism; strong communication and coordination skills and attention to details.

Awards & Recognition

June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work!

May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries!

October 2008, EMD Serono Named as a Top Employer by Science Magazine!

• more