Oncology Principal Medical Writer (Remote based- NC, SC, GA, TN) Job

3 days left

Raleigh NC
Sep 29, 2016
Oct 29, 2016
Organization Type
Oncology Principal Medical Writer (Remote based- NC, SC, GA, TN)-CLI005065


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Principal Medical
Writer (PMW) is a key member of the Medical Writing team. The PMW is responsible for development and management of medical
writing deliverables that support the clinical regulatory writing portfolio and
is capable of working independently to achieve goals. The PMW will
support the Oncology therapeutic area including Early or Late Phase

In this role the Principal
Medical Writer:

- Is recognized as a significant
scientific contributor and subject matter expert in preparation of
regulatory clinical documentation.

- Applies in-depth knowledge of
regulatory medical writing and therapeutic area/investigational product to
support pipeline projects. Represents functional area in cross-functional
teams (either internally or externally).

- Produces high-quality and
timely documentation in line with expectations. Interprets and applies knowledge
of regulatory/compliance/scientific requirements, using own judgment,
prior work experience, and broad appreciation of impact on other

- Leads and manages medical
writing projects including the design, planning, and preparation of clinical
documentation in support of clinical development (e.g., program level
standards), trials (e.g., CSRs), and filings (e.g., clinical modules).
Works collaboratively with colleagues across functions to achieve results.

- Solves complex problems
associated with medical writing scope of work, involving ambiguous
situations across departments and the need to develop new options to

- Oversees the work of other
medical writers, providing scientific and operational mentorship and
coaching in the design, planning, and execution of their assignments.
Provides feedback to their managers on development plans and performance

- Provides leadership for medical
writing processes, standards, and innovative initiatives.

is a remote based position. The ideal
candidate will be based in NC, SC, TN or GA.



- Required:

- Bachelor’s Degree in the
Life Sciences with at least 10 years of experience as a medical
writer preparing regulated documents in the pharmaceutical and/or biotech
industry OR

- MS Degree in the Life Sciences
with at least 8 years of experience as a medical writer preparing
regulated documents in the pharmaceutical and/or biotech industry OR

- PhD in the Life Sciences with
at least 6 years experience as a medical writer preparing regulated
documents in the pharmaceutical and/or biotech industry


- Ability to prepare,
without supervision, core clinical regulatory documents according to
company guidelines and international governmental regulations and to
present clinical data objectively in a clear, concise format in keeping
with industry guidelines.

- Provide leadership of and
management for complex documentation projects and project teams of medical

- Technical expertise in
Microsoft Office, Adobe Acrobat, document management systems, and
familiarity with SharePoint and concepts of structured content management.

- Excellent oral (including
presentation) and written communication, and project management skills.
Awareness of pharmaceutical industry needs beyond clinical development.

Preferred Experience:

- Successful preparation of
Common Technical Document clinical modules.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Clinical Research - Clin Ops

Job Title:Associate Principal Scientist, Clinical Operations

Primary Location: NA-US-NC-Raleigh

Other Locations: NA-US-North Carolina, NA-US-Tennessee, NA-US-Georgia, NA-US-South Carolina

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 3

Company Trade Name:Merck