ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director - Medical Writer on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

The Director of Medical Writing will lead the medical writing function and will coach and grow the team. The Director may function as a Lead Medical Writer on a variety of regulatory writing deliverables; will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. The Director will conduct senior review of medical writing deliverables (CSR, IBs, Protocols, etc.) and negotiate timelines and discuss/resolve clients’ comments. This role will provide written and verbal feedback to the internal team, and to clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development.

Lead the medical writing team – mentor the team and oversee all the aspects of project delivery for global clients.
Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the clients.
Plan and organize workload for assigned projects and tasks: identify project needs, track timelines, and implement clients’ requests.
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
Present on Medical Writing processes at full-service bid defense meetings.
Develop and deliver training to the global team in various aspects of medical writing.
Facilitate project budgeting activities for the medical writing scope by collaborating with the BD team.
Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables.
Oversight of a portfolio of clients. This includes, but not limited to:
Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality and capitalize on business development opportunities.
Provide scientific and technical guidance to the client and Medical Writers.
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
Keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
Serve as the primary client contact and Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.

Education and Experience:

At minimum a Bachelor’s degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
At least 10 to 15 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.
Experience working on end-to-end CSR, IBs, Protocols across different TAs is mandatory for pharmaceutical and medical device products. Experience in DSUR will be considered as an added advantage.
An understanding of the drug development process.
Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.
Experience in interacting with cross functional study team members.

Specific Role Requirements and Skills:

Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details.
Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed client and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
Read, write, and speak fluent English, excellent verbal, and written communication skills.
Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook.
Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.
Culturally aware and able to work comfortably within a global team.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Medical Writer, Medical Writing, Regulations, CSR, Clinical Writing, Scientific Writing

#LI-PB1 #LI-REMOTE #Director # Permanent

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

LinkedIn Profile

Website

Are you legally authorized to work in the country that you are being hired? *

If "yes", will you now or in the future require sponsorship to work in the country that you are being hired? *

What type of employment are you seeking? *

  Permanent
  Subcontractor
  Intern
  Temporary

Area of expertise - Therapeutic area or other skills

Have you previously worked for ClinChoice or its subsidiaries? If yes, please provide additional details

Do you have a friend or family member working for ClinChoice? If yes, please provide additional details.

Are you currently employed? *

Current Address

Date available to work? *

Employment History: Please list your two most recent employers, including name of the company, job title, and dates employed *

Are you willing to undergo a background check upon employment? *

If hired, can you furnish proof you are eligible to work in the country you are being hired? *

How did you hear about this opening? *

Will you relocate if the job requires it? *

How much are you willing to travel? *

Are you ok to work in a hybrid model work schedule? *

What is your desired salary/hourly rate? *

Please read and accept our privacy policy: *

https://clinchoice.com/privacy-policy/

US disclaimer: *

I certify all information provided in this employment application is true and complete. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date.

I authorize the investigation of any or all statements contained in this application and also authorize any person, school, current employer (except as previously noted), past employers and organizations’ names in this application to provide relevant information and opinions that may be useful in making a hiring decision. I release such persons and organizations from any legal liability in making such statements.

I understand if I am extended an offer of employment, it may be contingent upon my successfully passing a complete background and reference check. I hereby consent to any or all of these pre-employment test/screen/checks as a condition of employment, if required. I consent to the release of any or all medical information as may be deemed necessary to judge my capability to do the work for which I am applying.

I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME. IF EMPLOYED, I UNDERSTAND THAT I HAVE BEEN HIRED AT THE WILL OF THE EMPLOYER AND MY EMPLOYMENT MAY BE TERMINATED AT ANY TIME WITH OR WITHOUT CAUSE AND WITH OR WITHOUT NOTICE.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in ClinChoice’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Our system has flagged this application as potentially being associated with bot traffic. Please turn off any VPNs, clear your browser cache and cookies, or try submitting your application in a different browser. If this issue persists, please reach out to our support team via our help center.

Please complete the reCAPTCHA above.