http://bauschandlomb.jobs2web.com/go/New-Jersey-Manager-Jobs/118216/ View New Jersey Manager Jobs at Bausch and Lomb en-us http://basf.jobs2web.com/images/bauschandlomb/logo.gif http://bauschandlomb.jobs2web.com/go/New-Jersey-Manager-Jobs/118216/ 720 Job Title:
Regulatory Affairs Associate Director - Brand

Req #:
5340BR

Job Description:
The Global Regulatory Associate Director handles all regulatory development aspects for prescription brand ("Brand") products. Participates on the product development team to provide regulatory guidance for Pharmaceutical Brand products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for Brand products. May perform due diligence efforts on new product opportunities. Specific

Job Duties:
? Responsible for developing a global product regulatory strategy for Brand pharmaceutical products ? Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development ? Develop a product regulatory timeline aligned to Bausch & Lomb's product development, with key regulatory milestone, and activities for agency filing ? Coordinate with the Labeling Senior Manager for the development of product labels ? Ensure labeling content and product documentation is developed in accordance with regulatory requirements ? Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions ? Coordinate with Global Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities ? Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical Brand products ? Liaise with Bausch & Lomb country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations ? Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections ? Provide regulatory guidance/input to internal product review boards ? Manage assigned personnel Technical Competencies: ? Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations ? Knowledge of domestic and international laws, regulations, and guidance that affect Brand products ? Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses ? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products ? Ability to influence and partner with cross-functional teams in a global pharmaceutical organization ? Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval ? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data ? Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks Professional Competencies: ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead a team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Focused ability to influence operational excellence and performance metrics ? Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications
? 8+ years relevant pharmaceutical industry and regulatory experience ? Pharmaceutical brand experience highly preferred ? Bachelors degree in science or health related field ? Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director-Brand-Job-NJ-07940/656248/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director-Brand-Job-NJ-07940/656248/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Regulatory Affairs Director

Req #:
5343BR

Job Description:
Position Summary: The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb's pharmaceutical products throughout their lifecycle, which includes Brand, Generics, OTC/Nutritionals, and dietary supplements. Responsible for the overarching global pharmaceutical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Pharmaceutical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and CMC). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. Specific

Job Duties:
* Serve as a leadership team member for Bausch & Lomb's Pharmaceutical Regulatory Affairs function * Oversee the development of global product regulatory strategies for all Bausch & Lomb pharmaceutical products * Oversee the regulatory functions in relation to drug development and product approvals, consistent with Bausch & Lomb agreed upon timelines * Manage interactions with Regulatory Authorities for pharmaceutical products * Build relationships with Bausch & Lomb Global Regulatory Affairs function * Provide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections * Provide regulatory guidance/input to internal product review boards * Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance * Play a significant role in the performance management process and career development programs for supervised regulatory personnel Technical Competencies: * Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including * Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations * Knowledge of domestic and international laws, regulations, and guidance * Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization * Ability to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams * Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval * Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data Professional Competencies: * Strong capability to lead and support a collaborative team environment * Demonstrated ability in analytical reasoning and critical thinking skills * Ability to manage in a highly matrix organization * Demonstrated ability to lead a multidisciplinary team * Strong business acumen and ability to see the business drivers outside of Regulatory Affairs * Excellent communication skills; both oral and written * Strong interpersonal skills with the ability to influence others in a positive and effective manner * Demonstrated ability to contribute to a continuous learning and process improvement environment * Capacity to react quickly and decisively in unexpected situations * Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies * Focused ability to influence operational excellence and performance metrics * Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications
* 10+ years pharmaceutical industry and regulatory experience * Bachelors degree in science or health related field * Advanced degree highly preferred (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Director-Job-NJ-07940/656251/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Director-Job-NJ-07940/656251/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Regulatory Affairs Manager - Submissions

Req #:
5344BR

Job Description:
Position Summary: The Global Regulatory Affairs Submission Manager is responsible for working to execute timely and accurate product registrations. Responsible for working with the Advertising and Promotion Senior Manager and Labeling Senior Manager to ensure that all advertising, promotion, and labeling materials are submitted in accordance with post marketing reporting requirements to the appropriate Regulatory Authorities where applicable. Works closely with outsourced providers to oversee the submission of timely annual reports and the transmission of electronic submissions for pharmaceutical drug products. Specific

Job Duties:
* In conjunction with the Global Regulatory Support Services Director, responsible for developing and implementing the pharmaceutical regulatory submissions strategy that define Bausch & Lomb's approach for regulatory submissions and promote speed to market * Develop submission schedule aligned with product development pipeline to ensure timely submission and approval of applications, amendments, supplements, and other regulatory correspondence * Manage the compilation and publishing process for routine and regulatory submissions, including oversight of work being performed by contract vendors * Liaise with country-specific regulatory affairs submission personnel * Provide information for pharmaceutical product registrations * Responsible for preparing for global product registration variations and product renewals * Managed assigned personnel Technical Competencies: * Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations * Knowledge of current and emerging issues and trends of the regulatory environment within specialty area and ability to integrate such within the regulatory affairs organization * Knowledge of domestic and international regulations relating to the submission and regulatory approval * Ability to compile and file submissions to Global Regulatory Authorities * Knowledge of document management and electronic publishing systems (i.e., Documentum, Core Dossier, MS Office applications, Adobe Acrobat, MS Project). * Strong general technology skills and abilities * Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business * Ability to team with cross-functional groups in a global regulatory affairs organization * Capability to interpret regulatory authority policies and guidance and correctly apply them as appropriate to the submission process Professional Competencies: * Demonstrated ability in analytical reasoning and critical thinking skills * Strong capability to contribute and lead in a team environment * Strong interpersonal skills * Excellent communication skills; both oral and written * Demonstrated ability to contribute to a continuous learning and process improvement environment * Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies

Qualifications
* 8+ years relevant pharmaceutical industry and regulatory experience * Pharmaceutical submissions experience * Bachelors degree * Advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Manager-Submissions-Job-NJ-07940/656252/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Manager-Submissions-Job-NJ-07940/656252/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Sr. Brand Manager, Global OTC Pharmaceutical Marketing

Req #:
5116BR

Job Description:
PURPOSE: Lead the development of robust category level strategies for key global OTC pharmaceutical brands and therapeutic areas within Ophthalmology. Collaborates closely with the Regional teams, R&D Project Management, Regulatory and Medical to ensure successful global launches, in-market performance and life cycle management of key global brands. Develops brand plans and supports Regional implementation. RELATIONSHIPS: Reports to the Global Head of OTC Marketing within the Pharmaceuticals Business Unit. Leads the Global brands team and the extended cross-functional team. Interacts extensively with all areas of the business - particularly Regional Marketing and Sales, R&D Project Management, Regulatory, Medical and Business Development. ESSENTIAL FUNCTIONS: BRAND AND THERAPEUTIC AREA STRATEGY: Leads Global brand team and extended cross-functional team to ensure successful global launches, in-market performance and life cycle management of key prescription pharmaceutical brands. Defines robust therapeutic area strategy to strengthen the in-market and pipeline portfolio in close collaboration with the R&D, Business Development and Regional Marketing and Sales. Develops Global brand plans to maximize key pipeline and in-market brands, including global launch plans, positioning, branding, life cycle management and forecasting. Supports Regional implementation of brand plans and sharing best practices to ensure excellent in-market execution. Partners with Marketing Intelligence to generate insights on customer needs, competitive dynamics and brand positioning / performance and incorporate these into strategies / plans. Ensures excellent matrix management and develops strong relationships with key internal and external stakeholders. Participates in cross-functional projects and select business development opportunities. BUDGET: Oversees the global brand budget and ensures that resources are appropriately allocated and high quality deliverables are produced. DEVELOPMENT OF PEOPLE: Supports Regional / local brand managers and helps to build capabilities within the Global brand and cross-functional teams; develops clear brand / team KPIs. Manage the application and communication of all B&L policies and procedures.

Qualifications
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Bachelors Degree required. Masters degree preferred. 6 - 10 years relevant OTC Pharmaceutical marketing experience, demonstrating a steady career progression with increasing roles of responsibility. Prior experience launching a OTC Pharmaceutical product required. Prior experience in Global Marketing or in Marketing in more than one Region strongly preferred. Sales experience preferred. Strong analytical and quantitative analysis skills required. Strong influencing, cross-functional collaboration and customer service skills required. Ability to plan, organize, and deploy resources according to urgency/importance. Presentation/communications skills must be excellent. Strong Innovation and Adaptability: must be able to identify better ways of doing things and getting others excited about new approaches. OTHER: Works within B&L's established policies and procedures. Embraces B&L Values in spirit and actions. Up to 25% overnight travel.

Work Location NJ-Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Sr_-Brand-Manager,-Global-OTC-Pharmaceutical-Marketing-Job-NJ-07940/514695/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Sr_-Brand-Manager,-Global-OTC-Pharmaceutical-Marketing-Job-NJ-07940/514695/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Regulatory Affairs Associate Director, Advertising/Promotional Review

Req #:
5376BR

Job Description:
Position Summary: The Advertising and Promotion Associate Director serves as the regulatory lead for all Pharmaceutical promotional labeling and advertising materials. Serves as the primary interface with Regulatory Authorities on promotional issues. Specific

Job Duties:
? Represent Regulatory Affairs on the promotional review team to make certain all pharmaceutical advertising and promotional materials are in compliance with regulatory requirements and Bausch & Lomb policies ? Provide final approval of all pharmaceutical advertising and promotional labeling materials ? Monitor DDMAC activity, letters, guidance, and where applicable advise the company to the business impact ? For pharmaceutical Brand products, establish a working relationship with DDMAC reviewers ? Prepare launch packages for submission to DDMAC for comments as needed ? Provide regulatory training for marketing and sales regarding regulatory requirements necessary for the appropriate and legal promotion of products ? Represent Bausch & Lomb to Regulatory Authorities on all pharmaceutical promotional and advertising matters ? Manage assigned personnel Technical Competencies: ? Knowledge of pharmaceutical industry regulatory affairs discipline ? Knowledge of laws, regulations, and guidance in relations to pharmaceutical products ? Knowledge of PhRMA Code, CHPA, and GMA codes as well as other regulations and guidance related to product promotion ? Knowledge of key enforcement activities and ability to assess the changing regulatory environment to determine impact to Bausch & Lomb's pharmaceutical product line ? Ability to interpret regulatory policies and guidance and correctly apply, as appropriate, in product promotion and marketing materials ? Ability to influence and partner within Bausch & Lomb Regulatory Affairs and with cross-functional teams in a global pharmaceutical organization ? Ability to generate innovative solutions to regulatory issues ? Detail-oriented with the ability to proofread and check documents for accuracy, as well as the ability to relate information in review to requirements and to identify inconsistencies Professional Competencies: ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead a team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Focused ability to influence operational excellence and performance metrics ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications
? 8+ years relevant pharmaceutical industry and regulatory experience ? Previous experience within pharmaceutical advertising and promotional ? Bachelors degree ? Advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director,-Advertising-Promotional-Review-Job-NJ-07940/679093/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director,-Advertising-Promotional-Review-Job-NJ-07940/679093/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Drug Development Project Manager - Pharmaceuticals

Req #:
5369BR

Job Description:
Reporting to the Director, Pharmaceutical Project Management, the Project Manager will use the global PDP (Product Development Process), allied systems & tools, to plan and manage/coordinate resources and activities related to cost improvement & product development projects throughout Global R&D, and other B&L organizations.

Job Duties:
- Champion and lead projects for new product, cost improvement, and product improvement projects. - Management of projects in compliance with PDP process and procedures. - Management of project team members from the various other functional areas assigned to a specific program (includes team meetings, communications to teams and meeting minutes etc.). - Along with project team, lead the development and implementation of a project plan, schedule, budget and capital plan as required. - Review and monitor program/project activities against definition, schedule and costs. - Prepare amended budget forecasts as required. - Deliver products to agreed timelines and budgets. - Communicate effectively with RD&E management and staff regarding the

Status of all activities. - Inform management in a timely manner of any problems which may result in a delay in project schedules so that appropriate action may be taken. - Publish monthly/quarterly project report summaries as required. - Product presentations to development committee and senior management.

Qualifications
- Bachelors degree in science required with 10+ years of related experience. - 5 - 7 years pharmaceutical drug development project/program management experience with specific experience in managing complex, highly technical R&D/Drug Development related activities. Global experience a plus. - Prior training in project management. PMI certification a plus. - Proven, hands-on, results-oriented manager with demonstrated leadership skills across functional lines and a participatory style of working effectively in a dynamic, team-oriented environment. - Ability to communicate and interact at all levels from senior management to staff level. - Ability to translate customer requirements into measurable design goals/input. - Competency in Microsoft Project, Word, PowerPoint & Excel. - Excellent verbal, written and electronic communication skills. - Therapeutic area experience in ophthalmology, anti-infective or anti-inflammatory is preferred. - Proficiency in a foreign language (German, French) a plus.

Work Location NJ - Madison Relocation Available Yes Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Drug-Development-Project-Manager-Pharmaceuticals-Job-NJ-07940/671369/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Drug-Development-Project-Manager-Pharmaceuticals-Job-NJ-07940/671369/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Regulatory Affairs Director - Policy & Communications

Req #:
5308BR

Job Description:
Position Summary The Regulatory Affairs Policy and Communication Director serves as the primary individual for regulatory intelligence for all Bausch & Lomb pharmaceutical products globally. Understands and leads critical regulatory strategic thinking of Bausch & Lomb's role in shaping the external environment. Serves as the primary regulatory liaison for Pharmaceuticals with health authorities. Specific Job Duties ? Serve as a leadership team member for Bausch & Lomb Pharmaceutical Regulatory Affairs function ? Monitor the domestic and international regulatory landscape, including governmental and non-governmental regulations, practices, and guidance ? Understand industry leading practices and the competitive environment ? Navigate strategic issues for Bausch & Lomb pharmaceutical products ? Interpret, and communicate global regulatory intelligence findings (i.e., FDA guidance, OIG actions, EMEA directives, congressional proceedings, etc) that affect Bausch & Lomb's pharmaceutical business ? Interpret Regulatory Authority policies and guidance and provide counsel and training as appropriate to Regulatory Affairs personnel and the business ? Build external eminence with regulatory agencies and trade associations by developing strategic relationships that positively affect Bausch & Lomb interests ? Act as primary liaison with global Regulatory Authorities ? Support the development of a Global Regulatory policy for proactive management of receiving and disseminating critical regulatory information ? Coordinate and share information with global counterparts and other business divisions Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations ? Knowledge of current and emerging issues and trends of the pharmaceutical regulatory environment ? Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business ? Ability to influence external regulatory stakeholders and shape the external regulatory environment ? Ability to translate highly complex global regulatory requirements to assist the pharmaceutical organization to strategically manage regulatory risk and operationalize compliance ? Ability to influence and partner within regulatory and with cross-functional teams in a global pharmaceutical organization ? Ability to distill complex information and communicate effectively to the business Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong ability to lead and support a collaborative team environment ? Ability to assess project risks and where appropriate, recommend contingency plans and strategies to mitigate risks ? Strong ability to influence and lead in a high matrix global organization ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills at the executive level with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications
? 10+ years relevant pharmaceutical industry/ policy/ regulatory experience ? Proven leadership experience and established eminence within the Pharmaceutical industry ? Bachelors degree in science or health related field ? Advanced degree highly preferred (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Director-Policy-&-Communications-Job-NJ-07940/641703/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Director-Policy-&-Communications-Job-NJ-07940/641703/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Regulatory Affairs Associate Director - Support Services

Req #:
5309BR

Job Description:
Position Summary The Global Regulatory Affairs Support Services Associate Director provides leadership and direction for Pharmaceutical Regulatory "Operations" centers of excellence. Coordinates with other Bausch & Lomb regulatory functions to streamline regulatory operations and create a more effective regulatory operation. Specific Job Duties ? Serve as a leadership team member for Bausch & Lomb's Pharmaceutical Regulatory Affairs function ? Manage the overall operations of Pharmaceutical Regulatory Affairs, which is defined as the submissions, publishing, technology, training, and document management functions ? Identify opportunities to streamline and centralize Pharmaceutical Regulatory Affairs to promote operational excellence ? Monitor internal and external influences to regulatory operations, and coordinate with impacted teams to modify existing standards, policies, and procedures ? Provide guidance and oversight to global submissions and product registrations for Bausch & Lomb Policy and Regulatory Authority requirements ? Provide guidance and oversight into Regulatory Affairs outsourcing strategy and vendor relationships ? Provide direction and monitor compliance of mandated regulatory training to maintain compliance with Bausch & Lomb policies ? Provide oversight and monitor the Global Regulatory Standards Framework that defines who owns, maintains, and drives implementation of SOPS and work instructions ? Provide monthly operations reports on key performance indicators and vendor performance to create transparency of Regulatory Affairs effectiveness ? Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance ? Play a significant role in the performance management process and career development programs for supervised regulatory personnel Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations ? Knowledge of current and emerging issues and trends in the regulatory environment ? Knowledge of industry systems, tools, and technology that support an efficient and compliant regulatory organization ? Ability to identify training program curriculum that supports development and maintenance of skills for regulatory personnel ? Ability to apply regulatory knowledge to improve regulatory operations ? Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business ? Ability to influence and partner within regulatory and with cross-functional teams in a matrix global pharmaceutical organization ? Ability to assess project risks and where appropriate, recommend contingency plans and strategies to mitigate risks ? Ability to negotiate vendor contracts and establish service level agreements (SLAs) for regulatory affairs service providers Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute lead and support a collaborative team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Focused ability to operational excellence and performance metrics ? Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications
? 8+ years combined IT and pharmaceutical regulatory experience ? Regulatory operations experience highly preferred ? Bachelors degree ? Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director-Support-Services-Job-NJ-07940/641704/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Regulatory-Affairs-Associate-Director-Support-Services-Job-NJ-07940/641704/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS Job Title:
Associate Director, Clinical Affairs

Req #:
5368BR

Job Description:
Position Summary: Participate in pharmaceutical project development teams and facilitate regional and global clinical development. Accountable for expert ophthalmic contributions including the identification and evaluation of clinical scientific issues related to clinical trial implementation. Interpret clinical data and contribute to clinical study reports and related documentation required for pharmaceutical clinical development. Specific

Job Duties:
. Participate on pharmaceutical R&D teams as a clinical scientific representative. . Provide scientific expertise for pharmaceutical clinical development with respect to the planning and execution of clinical trials, including cross-functional collaboration and communication and global clinical scientific representation. . Provide input and oversight for all clinical scientific aspects of registrational trials including safety, tolerability and efficacy reporting. . Participate in global clinical development meetings, contribute to harmonized protocol designs, participate in and present clinical data during internal and external meetings and symposia. . Develop and maintain strong scientific relationships with medical experts in support of clinical development programs. . Manage all clinical scientific aspects of pharmaceutical clinical trials. . Ensure compliance with FDA regulations, GCP and ICH guidelines. . Identify and evaluate clinical scientific issues related to projects and implementation of sound resolutions. . Provide input on R&D departmental decisions related to processes and procedures.

Qualifications
Qualifications: .

Education:
MD or PhD required (MD, Ophthalmology preferred) . Experience: Minimum 5 years research, clinical trial or related experience. Must have excellent communication, organizational, and writing skills. .

Special Skills:
Experience with ophthalmic pharmaceuticals for the treatment of glaucoma and dry eye preferred. Demonstrated ability to train study personnel and study CRAs. Ability to manage multiple projects simultaneously. . Specialized Training: Experience/training in GCP, ICH, and/or FDA pharmaceutical regulations is beneficial.

Work Location NJ - Madison Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/MADISON-Associate-Director,-Clinical-Affairs-Job-NJ-07940/669168/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/MADISON-Associate-Director,-Clinical-Affairs-Job-NJ-07940/669168/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS