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

1 day left

Raleigh NC
Sep 29, 2016
Oct 24, 2016
Organization Type
Oncology Senior Medical Writer (Remote based- NC, SC, GA, TN)-CLI005072


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 Senior Medical
Writer (SMW) is a key member of the Medical Writing team. The SMW is
responsible for development and management of medical writing deliverables that
support the clinical regulatory writing portfolio and works with some guidance
and oversight to achieve goals. The SMW will support the Oncology therapeutic
area including Early or Late Phase development.

In this role the Senior
Medical Writer:

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

- Applies developing knowledge of
regulatory medical writing and therapeutic area/investigational product to
support pipeline projects. Participates as part of the medical writing
team in cross-functional teams (either internally or externally).

- Demonstrates competence in
writing, editing and reviewing of clinical study reports, investigator
brochures, registration dossier modules, and other clinical regulatory
documents in line with expectations. Able to interpret data and apply
knowledge of regulatory/compliance/scientific requirements to document

- Manages medical writing
projects including the design, planning, and preparation of clinical
documentation in support of clinical development, trials, and sections of
filings. Works collaboratively with colleagues across functions to achieve

- Solves problems associated with
medical writing scope of work, seeking advice from management and others
as needed, and exercising negotiation and communication skills with
project team members .

- May participate in orientation
and coaching of junior team members or contractor writers.

- May participate in initiatives
to improve medical writing processes and standards.

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



- Bachelor’s Degree in the Life
Sciences with a minimum of 6 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 a minimum of 3 years of experience as a medical writer
preparing regulated documents in the pharmaceutical and/or biotech
industry OR

- PhD in the Life Sciences
with a minimum of 1.5 years of experience as a medical writer
preparing regulated documents in the pharmaceutical and/or biotech


- Ability to prepare, with
minimal supervision a subset of clinical regulatory documents (e.g., CSR,
IB, clinical sections of IND/IMPD and CTD) according to company guidelines
and international governmental regulations and to present clinical data
objectively in a clear, concise format in keeping with industry

- Participate actively in medical
writing and cross-functional project teams.

- 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

- Awareness of pharmaceutical
industry needs beyond clinical development.

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:Sr. 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: 1

Shift (if applicable): 1st

Company Trade Name:Merck