Job Description
Reports to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)
The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.
Serve as the liaison and manages correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment
Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk
Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives.
Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders
Serves as a mentor within the department. Ability to take on more complex projects and provide promotional regulatory training and coaching to team members
Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review
Required Experience and Skills:
Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years of direct experience as the primary reviewer of advertising and promotional materials
Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products
Proactive with strong cross-functional collaboration skills
Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch
Understanding of the product development and labeling process
Excellent verbal and written communication skills
Attention to detail and ability to manage multiple priorities simultaneously.
Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
Demonstrated ability to negotiate and influence others effectively
Education:
Minimum Requirement: B.A. or B.S. degree with an emphasis in science, health care or related fields.
Preferred: Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
GRACSJOBS
#EBRG
Vetjobs
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
