Regulatory Counsel (GS-0301-13) - FDA (Silver Spring, MD)

See original job posting here.

Job Title:Regulatory Counsel, GS-0301-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:FDA-CDER-DE-14-1048846TM

SALARY RANGE:	$89,924.00 to $116,901.00 / Per Year
OPEN PERIOD:	Thursday, February 27, 2014 to Tuesday, March 18, 2014
SERIES & GRADE:	GS-0301-13
POSITION INFORMATION:	Full Time - Permanent
DUTY LOCATIONS:	Many vacancies in the following location: Silver Spring, MD View Map
WHO MAY APPLY:	United States Citizens
SECURITY CLEARANCE:	Not Applicable
SUPERVISORY STATUS:	No

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

As a Regulatory Counsel in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigation (OSI) or Office of Unapproved Drugs and Labeling Compliance (OUDLC), you will serve as a legal/regulatory expert resolving a broad range of legal/regulatory issues concerning the application of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-MP-14-1048589TM under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.

TRAVEL REQUIRED

• Not Required

RELOCATION AUTHORIZED

• No

KEY REQUIREMENTS

• U.S Citizenship
• Suitability for Federal employment determined by background investigation
• May be required to serve a one-year probationary period

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DUTIES:

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• Develops and revises regulations and guidance, advising on compliance with FDA's Good Guidance Practice regulations and other legal/regulatory issues.
• Reviews and drafts policy proposals and decisions.
• Performs legal/regulatory reviews of petitions raising issues with industry-wide effect.
• Provides technical guidance on procedures and methods involved in implementing new programs, guidance, and regulations.
• Informs management and staff on new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industry.
• Ensures legal/regulatory sufficiency of action packages for regulatory enforcement actions.
• Drafts/reviews proposals for new regulations and policy statements.

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QUALIFICATIONS REQUIRED:

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GS-13:  You must have at least one year of specialized experience, equivalent to the GS-12 level in the Federal service, that includes analyzing and evaluating statutes and regulations affecting technical regulatory and compliance programs; consulting management and staff on developing and implementing compliance policy and enforcement initiatives for matters affecting the regulation of products; and conducting a legal/regulatory review of an organization's policy and practices are compliant with Federal regulations, to include the Federal Food, Drug, and Cosmetic Act.

*Demonstrated experience in applying the Food, Drug, and Cosmetic Act must be reflected in your CV or resume.

All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.

Conditions of Employment:

1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

4. All qualification requirements must be met by the closing date of the announcement.

5. Financial Disclosure statement may be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses paid: Maybe

8. Bargaining Unit Position: Yes

9. Drug Screening Required: No

10. Recruitment incentives may be authorized: Maybe

11. Student loan repayment incentive authorized: No

12. Annual leave for non-federal service authorized: Maybe

HOW YOU WILL BE EVALUATED:

Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Qualified candidates will be assigned to the following quality categories:

Best Qualified - Applicants who have experience that is almost identical to those required by the position.

Well Qualified - Applicants who have experience that is very similar to those required by the position.

Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.

The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.

• Technical Knowledge in Regulatory Programs
• Legal Analyses and Research
• Oral Communication
• Written Communication

Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.

To preview the assessment questionnaire, click the following link:View Assessment Questions

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BENEFITS:

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The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retire_jobseekers.asp.

OTHER INFORMATION:

Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference, go to www.fedshirevets.gov. 

Career Transition Program: This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated 'well-qualified.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and hat documents to submit as a CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp

Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit http://www.sss.gov/.

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HOW TO APPLY:

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To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (EST) on Tuesday, March 18, 2014 to receive consideration.

* To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.

* Click the Submit My Answers button to submit your application package.

* It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.

To verify your application is complete, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login and click the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.  Your uploaded documents may take several hours to clear the virus scan process.

To return to an incomplete application, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login  and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.

To complete a hard copy assessment questionnaire and submit it via fax: Do not complete the steps below if you have already applied online to the questionnaire for this position.

1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

2) Print the 1203FX form to record your responses to the questionnaire.

3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to: 

1-478-757-3144.

REQUIRED DOCUMENTS:

• Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
• Responses to the Assessment Questionnaire

Other Supporting Documents: (Only submit if applicable to you)

• Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
• CTAP/ICTAP documentation

If you are unable to upload supporting document(s) online, you can fax them by completing the following steps:

1. Print out a Fax Cover Page @ http://staffing.opm.gov/pdf/usascover.pdf and complete the required information. The Vacancy ID is 1048846

2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Tuesday, March 18, 2014 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

AGENCY CONTACT INFO:

Mid-Atlantic Services Branch
Phone: (757)441-6765
Email: NORFOLKMAIL@OPM.GOV

Agency Information:
HHS OPM
1900 E St NW
Washington, DC
20415

Investigator/Consumer Safety Officer, U.S. Food & Drug Administration

The U.S. Food and Drug Administration’s Chicago office is now seeking candidates for investigator/ consumer safety officer positions.

Read the job announcement and apply here for the investigator/ consumer safety officer position in Chicago, IL or Bensenville, IL.

Selected description:
SALARY RANGE:
$34,659.00 to $68,267.00 / Per Year

OPEN PERIOD:
Thursday, March 13, 2014 to Wednesday, April 02, 2014

DUTY LOCATIONS:
Many vacancies in the following location:
Chicago, IL

JOB SUMMARY: Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance.

TRAVEL REQUIRED 50% or Greater, DOMESTIC AND INTERNATIONAL

KEY REQUIREMENTS
U.S. citizenship is required.

Only experience gained by closing date announcement will be considered.

One year probationary period may be required.

Mobility agreement required.

Valid driver's license required.

TRANSCRIPTS MUST BE SUBMITTED WITH APPLICATION.

DUTIES

Plans and conducts regulatory inspections and in-depth investigations of various establishments; such as manufacturers, warehouses, and retail shops.

Performs analyses and evaluation on data samples and documented information gathered during inspections and investigations.

Prepares final reports, position papers and other written documentation that supports investigative findings and recommendations.

Provides testimony in court regarding the conditions of the manufacturer and the circumstances surrounding the samples the incumbent has collected.

Executive Director - Women, Food & Agriculture Network (WFAN)

See the original job posting here.

SEEKING EXECUTIVE DIRECTOR

Are you passionate about advocating for women engaged in healthy food and farming? Do you have the skills to build capacity of a growing national non-profit organization? Women, Food and Agriculture Network (WFAN), a 501(c)3 non-profit organization, is seeking a new executive director to take our growing network to the next level and expand this network to engage more women involved in all aspects of healthy food and farming.

WFAN’S HISTORY, MISSION AND PROGRAMS

Women, Food and Agriculture Network (WFAN) was founded in 1997 by a group of visionary women to address the absence of female voices in agriculture. It has grown into a premiere national network of more than 4,000 women across the U.S., providing education, leadership development and networking opportunities.

The mission of WFAN is to link and empower women to build food systems and communities that are healthy, just, sustainable, and that promote environmental integrity. Our dedicated staff and volunteer board of directors are mostly based in Iowa and a national advisory council is being created in 2014 to provide a broader scope of perspectives from various network constituents across the U.S.

We fulfill our mission by maintaining a community of women engaged in healthy food and farming nationwide through in-person meetings and conferences, our website (www.wfan.org), our newsletter, listserv, online forum, social media presence, and through three primary programs:

Women Caring for the Land (SM) supports and educates women farmland owners who want to improve soil and water conservation on the land they own, through web resources and women-only learning circles meetings. (www.womencaringfortheland.org)

Harvesting Our Potential (SM) provides aspiring and beginning women farmers with networking, business planning education, and on- and off-farm mentorship opportunities with experienced women farmers.

Plate to Politics (SM) helps women ramp up their leadership in healthy food and farming from the farmhouse to the White House, through online and in-person leadership development training. (www.platetopolitics.org)

ROLE OF THE EXECUTIVE DIRECTOR

Reporting to the board of directors, the executive director will be WFAN’s public face and speak for the organization on a regular basis. She will be in charge of all day-to-day operations, and have overall strategic and operational responsibility for WFAN’s staff, programs, expansion, and execution of its vision and mission. She will develop deep knowledge of WFAN’s programs, operations, and organizational plans. The executive director is also WFAN’s chief fundraiser, responsible for raising the organization’s budget and expanding the organization’s development and individual donor campaigns.

All candidates should have proven non-profit leadership, financial management, and relationship management experience. The successful candidate will demonstrate that she has the skills to move our growing organization from being funded primarily through grants to a more diverse funding portfolio, including a robust individual donor program. In addition, she must build upon our current growth and momentum to add to the size and effectiveness of WFAN by educating and advocating for women working in healthy food and sustainable agriculture across the nation.

QUALIFICATIONS

Required:

• Experience and/or education to equal 5 years of experience with a similar non-profit organization
• Proven track record of successful grant writing and fundraising
• Experience with financial management including grant oversight, project and organizational budgeting, and personnel management in a non-profit setting
• Experience planning conferences and events
• Ability to motivate, guide and supervise a decentralized staff
• Capacity to manage a staff and interact with a board that will continue to be based in Iowa
• Progressive viewpoint on, and familiarity with, current issues in healthy food and sustainable agriculture, specifically those relevant to women
• Demonstrated strength in verbal and written communications skills
• Willingness and capacity to travel within Iowa and nationally for conferences and other meetings

Strongly preferred:

• Proven track record of building and maintaining partnerships and alliances with local, regional and national organizations engaged in similar work
• Experience building grassroots networks and managing advocacy campaigns
• Mastery of a wide range of communications tools including email marketing (such as iContact), online form builder (such as Wufoo), WordPress, Google Groups, Facebook and Twitter
• Residency in or near Iowa, as most of the governing board and staff are located in Iowa, and our organization is an important member of the sustainable agriculture community in this primarily commodity agriculture-driven state
• Strong familiarity with Microsoft Office Suite, desktop publishing (Pages or InDesign), and online donor management software such as DonorSnap

COMPENSATION

Full time position strongly preferred, with paid vacation, holidays, and additional benefits including retirement fund options. Salary negotiable.

APPLICATION PROCESS

Please submit a cover letter addressing how you meet the above qualifications, resume, 4 professional references, and 2 writing samples (excerpts are fine, 3 pages max.) to wfanjobs@wfan.org no later than 5pm central time on March 24, 2014. Applications will be reviewed on a rolling basis, so early application is strongly recommended. Please put “Executive Director Application” in the subject line. Questions regarding the position announcement can be directed to Steph Larsen (StephL@cfra.org) or Dana Foster (Dana@Scattergood.org).

NOTE: This position will remain open until after the March 24 application deadline.

WFAN is an equal opportunity employer.

Union of Concerned Scientists: Food Systems and Health Analyst

The Union of Concerned Scientists (UCS) is hiring for a full-time, 2-year position in their Washington, DC office, joining the Food & Environment Team.

 Food Systems and Health Analyst

Food Systems and Health Analyst (Temporary – 2 Years)
Food and Environment Program
Washington, DC Office

Under direction of the Deputy Director/Senior Analyst, work as a member of an interdisciplinary team to advance policy advocacy efforts leading to a healthy, sustainable food and farming system. As the team’s health sciences expert, develop and maintain comprehensive knowledge of the food system’s impacts on nutrition, public health, and health disparities; conduct science-based research and analysis to advance understanding of these impacts and the policy choices that drive them; produce publicly-resonant scientific and policy analyses; craft written communications for a variety of audiences; cultivate relationships with experts and allies; represent UCS to policy makers, the media, and other stakeholders; and help develop program direction and plans. 

This is a full-time, two-year position with a possibility of renewal.

 Responsibilities

• Working as part of an interdisciplinary team, provide lead health sciences to the planning, design, and implementation of research activities and projects that advance healthy, sustainable food and agriculture systems.
• Develop and maintain comprehensive knowledge of public health analytical tools and food system issues, and utilize expertise in implementing research and advocacy activities; help develop and implement research methodologies; conduct literature reviews and searches to monitor and assess current and ongoing research and trends; gather and analyze data using databases, models and other appropriate analytical tools; write reports and other materials based on these analyses.
• Collaborate with analytic, policy, outreach, and media staff to apply research results and conclusions to the formulation and development of public policies, political strategies, media outreach, and other communication efforts; track and evaluate proposed legislation and regulations and develop alternatives.
• Represent UCS, its mission, goals, and positions at workshops, hearings, conferences, and other forums; present and promote UCS ideas, objectives, and activities; educate participants about political, environmental, social and economic dimensions of food and farming issues, with emphasis on the health benefits of sustainable agriculture and local and regional food systems.
• Provide technical and strategic assistance to policy makers, opinion leaders and coalition partners, and respond to inquiries and comments; establish and maintain alliances with advocates, healthy food businesses, modelers, and researchers at other organizations.
• Work with program and UCS communications staff to identify key media opportunities; serve as direct contact to the media; draft and edit press materials and content for UCS web site; write for the UCS blog.
• Help develop program objectives, strategies, and work plans, and contribute to foundation proposals, reports, workgroups and planning processes. Perform other related functions as directed.

  Qualifications and experience

Masters’ degree in public health, nutrition/dietetics, epidemiology, or related field and three to five years of relevant experience in food systems; familiarity with public policy process regarding agriculture and food systems; demonstrated ability to produce analyses on science policy issues and write about complex policy and scientific matters for a lay audience; understanding of the role of science  and advocacy in shaping public opinion and policy debates; excellent interpersonal skills and ability to work effectively as a member of a team. Project management skills and experience are also preferred. NGO experience is preferred but not essential.

At UCS, comparable training and/or experience can be substituted for degrees when appropriate.

 Compensation, Hours and Location:  This is a full-time, two-year position (with a possibility of renewal) based in UCS’s Washington, DC, office. For candidates who meet all position requirements, the salary is in the low $60,000s. UCS offers excellent benefits and a rewarding work environment, and is an equal opportunity employer continually seeking to diversify its staff and to broaden opportunities for individuals from demographic groups that are historically underrepresented in the sciences and in environmental advocacy.

To Apply: Please submit a cover letter, salary requirements, how you learned about the position and resume via email to jobs@ucsusa.org and include “Food Systems and Health Analyst” in the subject line. Email materials in Word or PDF format only. No phone calls please. Deadline: March 23, 2014 or until filled.

Land Use and Sustainable Development Law Fellow - West Virginia University College of Law

See original job posting here.

West Virginia University College of Law’s Land Use and Sustainable Development Law Clinic is now accepting applications for the Land Use and Sustainable Development Law Fellowship. The fellowship combines the opportunity to work with attorneys, planners and students at one of the leading Land Use Clinics in the United States with the opportunity to obtain the WVU Law LL.M. degree in Energy and Sustainable Development Law. The LL.M. program provides a uniquely deep and balanced curriculum in perhaps the nation’s richest natural resource region.

Land Use and Sustainable Development Law Clinic

The Land Use and Sustainable Development Law Clinic (LUSD Law Clinic) provides legal services to local governments, landowners and non-profit organizations to develop land conservation strategies and practices. Legal services include, but are not limited to, title examinations, advising landowners and land trusts, drafting conservations easements, negotiating with mineral owners/lessees, working with communities to identify alternative wastewater solutions, drafting comprehensive plans and zoning ordinances, training local officials on land use issues, and facilitating public meetings.

LL.M. in Energy and Sustainable Development Law

The WVU College of Law LL.M. in Energy and Sustainable Development Law is the only LL.M. program in the United States that provides a balanced curriculum in both energy law and the law of sustainable development. Working with WVUCollege of Law’s Center for Energy and Sustainable Development, LL.M. students will develop the expertise to advise clients and provide leadership on matters covering the full range of energy, environmental and sustainable development law.

The LL.M. in Energy and Sustainable Development Law provides a broad and deep offering of courses, experiential learning opportunities, and practical training for every part of the energy sector. Our broad spectrum of courses allows our students to prepare to be lawyers serving energy companies, investors, environmental organizations, landowners, utilities, manufacturing companies, lawmakers, policymakers, regulators and land use professionals.

Land Use and Sustainable Development Law Fellow

This fellowship is a part-time (at least twenty hours per week), two-year position from August 2014 through July 2016. The Fellow will receive an annual stipend of $20,000 and tuition remission for the LL.M. program. The Fellow would take 6-7 credits per semester allowing time for part-time work at the Clinic.

The position involves policy and legal research and writing; facilitating public meetings and workshops; supervising law students in the LUSD Law Clinic; and administrative responsibilities as needed. Many of our clients and partners work throughout the state and some travel is expected.

The Fellow will support all aspects of the Clinic’s missions in the areas of land conservation, land use planning, alternative wastewater solutions and the education of law students in these areas. There is frequent overlap in the areas of energy and land use planning, including the reduction of vehicle miles travelled, energy siting, and energy efficient buildings. Efforts will be made to match project assignments with the Fellow’s interest.

Fellowship Qualifications

Candidates should possess a J.D.; a strong academic record; excellent analytical and writing skills; a demonstrated interest and background in land use and sustainable development law and policy; and admission to the LL.M. program at West Virginia University (application for LL.M. admission can occur concurrently with the fellowship application). Preference will be given to candidates who have relevant experience in law, land use, or sustainable development. Admittance to the West Virginia Bar is preferred.

Applicants should apply to Samatha.Stefanov@mail.wvu.edu. Please submit a letter discussing qualifications and interests, a resume, a law school transcript, a recent writing sample and contact information for three references.

We are now accepting applications. The application deadline is June 1, 2014 or until the post is filled.

Visit our website at landuse.law.wvu.edu for more information about our programs.

West Virginia University College of Law is an equal opportunity employer and has a special interest in enriching its intellectual environment through further diversifying the range of perspectives represented by its faculty and teaching staff.