Job Description
We are seeking an experienced and dynamic Principal Medical Writing Manager to join our team and lead the development of clinical regulatory documents across our Translational Medicine (TMed) portfolio. This is an opportunity to make a significant impact in a collaborative and fast-paced environment at the forefront of medical research and development.
The Principal Medical Writing Manager will:
- Lead and manage a team of medical writers and clinical technical editors to ensure the timely and high-quality delivery of clinical regulatory documents, including protocols, pivotal clinical study reports, and submission documents, in accordance with company and regulatory requirements.
- Serve as a subject matter expert in Protocol, CSR templates, processes and authoring platforms, and medical writing processes and standards, providing guidance, mentorship, and training to the medical writing team to enhance their skills and expertise.
- Independently leads and authors clinical regulatory documents (e.g., protocols, pivotal clinical study reports, clinical sections of submission, etc.) across all therapeutic areas per company and regulatory requirements.
- Demonstrates expertise in document planning and authoring, and interpretation of data, using own judgment and prior work experience.
- Is recognized as a strong scientific contributor and works collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.
- Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products.
- Applies 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.
- Oversees the TMed portfolio of medical writing deliverables, stepping in where needed to cover resource gaps.
Want more jobs like this?
Get jobs in Boston, MA delivered to your inbox every week.
Minimum 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 clinical medical writing experience in the pharmaceutical and/or biotech industry supporting global filings.
- Experience managing complex writing projects and leading project teams of medical writers and cross-functional members.
- Experience in managing people and a portfolio of work.
- Ability to independently prepare a diverse set of clinical regulatory documents (e.g., study protocols, clinical study reports, clinical sections of submissions, etc) per regulatory requirements and industry guidelines.
- Ability to critically analyze and present clinical data clearly and objectively, without supervision.
- Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change.
- Excellent oral and written communication and presentation skills.
#EBRG
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.
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, Monday - 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".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:
$181,600.00 - $285,800.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R315028