Job Description

　　The Director, Medical Writing is responsible for managing medical writing deliverables and teams that support the clinical regulatory writing portfolio. The Director:

　　Provides leadership, strategic, and scientific expertise for the preparation of clinical regulatory documents across multiple programs and/or therapeutic areas (e.g., identification of and developing strategic plans for document deliverables, timelines, resources, review cycles, and escalation/mitigation process).Independently leads and authors clinical regulatory documents (e.g., study protocols, pivotal clinical study reports, clinical sections of submissions, regulatory responses) per company and regulatory requirements.Demonstrates in-depth expertise as a subject matter expert in document planning and authoring and interpretation of data, using own judgment and prior work experience.Is recognized as a significant scientific contributor and works collaboratively on cross-functional teams while demonstrating an in-depth understanding of team and project leadership responsibilities.Applies advanced knowledge of clinical development, relevant regulations, disease areas, and company products.Demonstrates an understanding of the pharmaceutical industry beyond clinical research.Applies advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.Demonstrates expertise in medical writing-specific tools and technology platforms.Provides leadership in initiatives to improve medical writing processes and standards.Provides scientific and operational mentorship, coaching, and project oversight to support other medical writers,May have management of direct reports including assignment of resources, professional development, and performance management

　　Qualifications, Skills & Experience:

　　Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).Bachelor's degree with 9+ years, master's degree with 8+ years, or doctorate degree with 7+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.Ability to independently lead and prepare any clinical regulatory document (eg., study protocols, clinical study reports, clinical sections of submissions, regulatory responses) per regulatory requirements and industry guidelines.Ability to critically analyze and present clinical data clearly and objectively.Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change.Experience managing complex writing projects and leading project teams of medical writers and cross-functional members.Excellent oral and written communication and presentation skills.Technical expertise in typical office applications (e.g., Microsoft Office Suite) and in shared document systems (e.g., SharePoint) and concepts of structured content management.2-4 years of people management experience with direct reports preferred.

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　　NOTICEFORINTERNALAPPLICANTS

　　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.

　　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.

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　　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:

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　　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".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

　　Expected salary range:

　　$175,440.00 - $276,200.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

　　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:

　　Hybrid, Remote Work

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　n/a

　　Requisition ID:R273338