Senior Medical Writer
Company: Syner-G BioPharma Group
Posted on: November 26, 2022
Are you a Medical Writer who enjoys authoring, editing, and
reviewing scientific and regulatory documents that progress
therapeutics aimed at improving health outcomes and saving lives?
Would you like the opportunity to participate on a variety of
documents across many therapeutic areas? If so, we are looking for
experienced Medical Writers to join our growing team and would love
to hear from you! In this client-facing role, you will work
collaboratively with IMPACT team members to author, edit, and
review documents such as clinical study reports (CSRs), subject
narratives, clinical sections of INDs, NDAs and BLAs, protocols,
and/or briefing documents. In addition to independently writing
documents, you may serve as a project manager for more complex
writing projects and act as a mentor to train and develop
early-in-career medical writers. This is a great opportunity for an
experienced Medical Writer who would like greater exposure to a
variety of clients, document types, and therapeutic areas. Your
- PhD, PharmD or MD in life or health sciences and approximately
3 years of regulatory medical writing experience in a
pharmaceutical company, contract research organization (CRO) or
comparable organization; or,
- Undergraduate degree in life or health sciences and
approximately 3-5 years of regulatory medical writing experience in
a pharmaceutical company, CRO, or comparable organization. Your
skills and abilities
- CRO/Pharma industry knowledge; current best practices and
regulations for the scientific documents noted above, drug
development cycles, and regulatory standards.
- Experience with independently authoring CSRs, Protocols and
Submission Documents, such as IND components and/or NDA components
(Integrated Summaries and Clinical Summaries).
- Strong analytical skills; ability to understand and interpret
complex clinical and scientific data and formulate those data into
a well-thought out and reviewer friendly manner.
- Clear written communication skills; ability to present written
results in an understandable manner to a variety of audiences.
- Excellent verbal communication skills; experience with leading
and facilitating discussions with internal project teams and
clients/sponsors (such as roundtable meetings.)
- Strong attention to detail; experience with Quality Control
(QC) and editing of scientific documents.
- Collaborative project management skills; demonstrated ability
to prioritize multiple projects and timelines.
- Broad software proficiency; strong knowledge of MS Word, Excel,
PowerPoint, Outlook, Adobe Acrobat. Your responsibilities
- Independently author and review a broad range of clinical,
scientific, and regulatory submission documents within a team
environment. Documents include, but are not limited to CSRs,
subject narratives, clinical sections of INDs, NDAs and BLAs,
protocols, and/or briefing documents.
- Contribute to the development of client timelines; contribute
to and facilitate internal and client meetings.
- Mentor, train, and coach early-in-career medical writers.
- Perform internal document reviews, editing, and QC as needed.
Who we are Impact Pharmaceutical Services, LLC (IMPACT) is a CRO
located in Research Triangle Park, NC, that specializes in
providing a range of drug development services for the
pharmaceutical and biotech industries, including medical writing,
QC, regulatory affairs, regulatory operations, and project and
program management. At IMPACT, our goal is to produce high-quality
deliverable documents that are sound from both scientific and
regulatory standpoints for every client on every project. Our
experienced employees and our honest, transparent, and flexible
approach have led to trusted, long-lasting relationships with our
clients, who consider us an extension of their project teams. As an
employee, you will experience us leading with our core purpose, "To
develop and inspire pharmaceutical professionals," and through our
core values of quality, integrity, flexibility, and responsiveness.
We encourage open, two-way communication throughout the company and
provide a supportive and encouraging working environment that
allows employees to reach their greatest potential. At IMPACT, we
realize the vital role a positive work/life balance plays in
establishing a rewarding, productive, and long-term career. As a
result, a flexible, family-friendly work environment is a key
element of our culture and is one of the reasons people want to
work (and stay) here! We offer an outstanding total rewards
package, including a competitive base salary and annual incentive
plan, robust benefit plans, and ongoing recognition and career
development opportunities. Employees also enjoy our generous paid
time off program, paid holidays, flexible working hours, and fully
remote work option. Impact Pharmaceutical Services, LLC is
committed to equal opportunity in the terms and conditions of
employment for all employees and job applicants without regard to
race, color, religion, sex, sexual orientation, age, gender
identity or gender expression, national origin, disability, or
veteran status. IMPACT is an E-Verify employer.
Keywords: Syner-G BioPharma Group, Boston , Senior Medical Writer, Advertising , Southborough, Massachusetts
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